Investors interested in Medical - Instruments stocks are likely familiar with Integra LifeSciences (IART - Free Report) and Masimo . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look.
There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style Scores highlight companies with specific traits.
Integra LifeSciences and Masimo are sporting Zacks Ranks of #2 (Buy) and #3 (Hold), respectively, right now. This means that IART's earnings estimate revision activity has been more impressive, so investors should feel comfortable with its improving analyst outlook. But this is just one factor that value investors are interested in.
Value investors analyze a variety of traditional, tried-and-true metrics to help find companies that they believe are undervalued at their current share price levels.
Our Value category highlights undervalued companies by looking at a variety of key metrics, including the popular P/E ratio, as well as the P/S ratio, earnings yield, cash flow per share, and a variety of other fundamentals that have been used by value investors for years.
IART currently has a forward P/E ratio of 6.48, while MASI has a forward P/E of 30.99. We also note that IART has a PEG ratio of 1.10. This metric is used similarly to the famous P/E ratio, but the PEG ratio also takes into account the stock's expected earnings growth rate. MASI currently has a PEG ratio of 1.81.
Another notable valuation metric for IART is its P/B ratio of 1.17. The P/B ratio is used to compare a stock's market value with its book value, which is defined as total assets minus total liabilities. For comparison, MASI has a P/B of 11.86.
Based on these metrics and many more, IART holds a Value grade of B, while MASI has a Value grade of D.
IART sticks out from MASI in both our Zacks Rank and Style Scores models, so value investors will likely feel that IART is the better option right now.
It has been about a month since the last earnings report for Integra LifeSciences (IART - Free Report) . Shares have added about 15% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Integra due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important catalysts.
Integra Q1 Earnings & Revenues Beat Estimates Integra LifeSciences Holdings Corporation (IART - Free Report) delivered adjusted earnings per share (EPS) of 54 cents for the first quarter of 2026, which beat the Zacks Consensus Estimate by 32.8%. The metric increased 31.7% year over year.
GAAP loss per share was 6 cents in the quarter compared with the year-ago period’s loss of 33 cents.
IART’s RevenuesTotal revenues in the first quarter rose 2.4% year over year to $391.9 million. The metric topped the Zacks Consensus Estimate by 2.7%. Organically, revenues rose 1.3% year over year.
Integra’s 2026 & Q2 GuidanceFor full-year 2026, the company expects revenues to be in the range of $1.66-$1.70 billion, representing reported growth of 1.6% to 4.1%. The Zacks Consensus Estimate is pegged at $1.67 billion, indicating 2.2% year-over-year growth.
Meanwhile, the company updated its expected adjusted EPS to a range of $2.40-$2.50. The Zacks Consensus Estimate for the metric is pegged at $2.42 per share.
For the second quarter of 2026, Integra expects reported revenues in the range of $410-$425 million. The Zacks Consensus Estimate is pegged at $417.5 million.
Adjusted EPS is expected to be in the range of 44-52 cents. The Zacks Consensus Estimate for the metric is pegged at 49 cents per share.
How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in estimates review.
The consensus estimate has shifted -10.74% due to these changes.
VGM ScoresCurrently, Integra has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. However, the stock has a grade of B on the value side, putting it in the top 40% for value investors.
Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Integra has a Zacks Rank #2 (Buy). We expect an above average return from the stock in the next few months.
Performance of an Industry PlayerIntegra belongs to the Zacks Medical - Instruments industry. Another stock from the same industry, Integer (ITGR - Free Report) , has gained 5.3% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026.
Integer reported revenues of $439.58 million in the last reported quarter, representing a year-over-year change of +0.5%. EPS of $1.20 for the same period compares with $1.31 a year ago.
For the current quarter, Integer is expected to post earnings of $1.38 per share, indicating a change of -11% from the year-ago quarter. The Zacks Consensus Estimate has changed -4.2% over the last 30 days.
Integer has a Zacks Rank #4 (Sell) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D.
It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.
Featuring daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, the research service can help you become a smarter, more self-assured investor.
Zacks Premium also includes the Zacks Style Scores.
What are the Zacks Style Scores? Developed alongside the Zacks Rank, the Zacks Style Scores are a group of complementary indicators that help investors pick stocks with the best chances of beating the market over the next 30 days.
Each stock is given an alphabetic rating of A, B, C, D or F based on their value, growth, and momentum qualities. With this system, an A is better than a B, a B is better than a C, and so on, meaning the better the score, the better chance the stock will outperform.
The Style Scores are broken down into four categories:
Value ScoreFinding good stocks at good prices, and discovering which companies are trading under their true value, are what value investors like to focus on. So, the Value Style Score takes into account ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and a host of other multiples to highlight the most attractive and discounted stocks.
Growth ScoreGrowth investors are more concerned with a stock's future prospects, and the overall financial health and strength of a company. Thus, the Growth Style Score analyzes characteristics like projected and historic earnings, sales, and cash flow to find stocks that will see sustainable growth over time.
Momentum ScoreMomentum investors, who live by the saying "the trend is your friend," are most interested in taking advantage of upward or downward trends in a stock's price or earnings outlook. Utilizing one-week price change and the monthly percentage change in earnings estimates, among other factors, the Momentum Style Score can help determine favorable times to buy high-momentum stocks.
VGM ScoreIf you like to use all three kinds of investing, then the VGM Score is for you. It's a combination of all Style Scores, and is an important indicator to use with the Zacks Rank. The VGM Score rates each stock on their shared weighted styles, narrowing down the companies with the most attractive value, best growth forecast, and most promising momentum.
How Style Scores Work with the Zacks Rank The Zacks Rank is a proprietary stock-rating model that harnesses the power of earnings estimate revisions, or changes to a company's earnings expectations, to help investors build a successful portfolio.
#1 (Strong Buy) stocks have produced an unmatched +23.7% average annual return since 1988, which is more than double the S&P 500's performance over the same time frame. However, the Zacks Rank examines a ton of stocks, and there can be more than 200 companies with a Strong Buy rank, and another 600 with a #2 (Buy) rank, on any given day.
But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from.
That's where the Style Scores come in.
To maximize your returns, you want to buy stocks with the highest probability of success. This means picking stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you find yourself looking at stocks with a #3 (Hold) rank, make sure they have Scores of A or B as well to ensure as much upside potential as possible.
As mentioned above, the Scores are designed to work with the Zacks Rank, so any change to a company's earnings outlook should be a deciding factor when picking which stocks to buy.
Here's an example: a stock with a #4 (Sell) or #5 (Strong Sell) rating, even one with Style Scores of A and B, still has a downward-trending earnings outlook, and a bigger chance its share price will decrease too.
Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.
Stock to Watch: Integra LifeSciences (IART - Free Report) Headquartered in Plainsboro, NJ, Integra LifeSciences Holdings Corporation is one of the world leaders in regenerative medicine. The company develops, manufactures and markets surgical implants and medical instruments. In its first-quarter 2026 report, the company renamed two of its segments: Codman Specialty Surgical was renamed Specialty Surgery, while Tissue Technologies was renamed Tissue Reconstruction.
IART is a #2 (Buy) on the Zacks Rank, with a VGM Score of B.
It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 7.01; value investors should take notice.
Three analysts revised their earnings estimate upwards in the last 60 days for fiscal 2026. The Zacks Consensus Estimate has increased $0.10 to $2.42 per share. IART boasts an average earnings surprise of +16.8%.
With a solid Zacks Rank and top-tier Value and VGM Style Scores, IART should be on investors' short list.
Capricorn Fund Managers Ltd purchased a new position in shares of Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Free Report) during the 4th quarter, according to its most recent disclosure with the Securities and Exchange Commission. The firm purchased 124,611 shares of the company’s stock, valued at approximately $3,006,000.
A number of other hedge funds and other institutional investors have also modified their holdings of CWAN. FNY Investment Advisers LLC lifted its stake in shares of Clearwater Analytics by 339.8% during the fourth quarter. FNY Investment Advisers LLC now owns 15,000 shares of the company’s stock valued at $361,000 after buying an additional 11,589 shares during the period. Trust Point Inc. acquired a new position in Clearwater Analytics in the 4th quarter valued at $221,000. Norden Group LLC purchased a new position in shares of Clearwater Analytics during the 4th quarter worth $313,000. First Bank & Trust acquired a new stake in shares of Clearwater Analytics during the fourth quarter worth $223,000. Finally, Congress Asset Management Co. grew its position in shares of Clearwater Analytics by 18.8% in the fourth quarter. Congress Asset Management Co. now owns 839,499 shares of the company’s stock valued at $20,249,000 after purchasing an additional 132,569 shares during the period. 50.10% of the stock is currently owned by hedge funds and other institutional investors.
Clearwater Analytics News Roundup Here are the key news stories impacting Clearwater Analytics this week:
Positive Sentiment: Institutional buying: Several large funds have recently increased positions (AQR, UBS, Woodline), signaling continued institutional interest that can stabilize the share base. Institutional Holdings Report Neutral Sentiment: Analyst stance is largely muted (consensus “Hold”) and several brokers have price targets clustered near the mid-$20s; that suggests limited near-term upside from analyst revisions. Neutral Sentiment: Insiders still retain large stakes (CEO Sandeep Sahai remains a >1.4M-share holder), which reduces—but does not eliminate—concerns that executives are exiting entirely. CEO SEC Filing Negative Sentiment: Clustered insider selling: Multiple senior officers sold shares the same day (CEO, CFO, CTO, CRO and another insider — ~127k shares total, ~ $3M at reported prices). Clustered top-executive sales often weigh on sentiment because they look like officers taking money off the table. Insider Trades Negative Sentiment: Options flow indicates downside positioning: unusually large put buying (~17,402 puts, ~+71% vs. average daily put volume), which can increase short-term selling pressure and volatility. Negative Sentiment: Shareholder litigation/investigation: Plaintiffs’ firm Scott+Scott launched an investigation into whether Clearwater’s directors breached fiduciary duties tied to the proposed buyout by Warburg Pincus and Permira — legal scrutiny can delay the transaction, add uncertainty to deal terms, and create potential liability. Investor Alert Insider Buying and Selling at Clearwater Analytics In other Clearwater Analytics news, CFO James S. Cox sold 21,631 shares of the stock in a transaction on Tuesday, March 31st. The shares were sold at an average price of $23.80, for a total transaction of $514,817.80. Following the transaction, the chief financial officer directly owned 485,419 shares in the company, valued at $11,552,972.20. This represents a 4.27% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which is available through this link. Also, CRO Scott Stanley Erickson sold 18,790 shares of the firm’s stock in a transaction on Tuesday, March 31st. The stock was sold at an average price of $23.80, for a total transaction of $447,202.00. Following the transaction, the executive directly owned 155,119 shares of the company’s stock, valued at approximately $3,691,832.20. This represents a 10.80% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. In the last three months, insiders have sold 780,842 shares of company stock valued at $18,360,889. Corporate insiders own 3.31% of the company’s stock.
Analyst Upgrades and Downgrades Several equities analysts recently weighed in on the company. Jefferies Financial Group downgraded Clearwater Analytics to a “hold” rating in a research report on Friday, January 16th. William Blair reaffirmed a “market perform” rating on shares of Clearwater Analytics in a research note on Monday, December 22nd. Warburg Research set a $24.55 price objective on shares of Clearwater Analytics in a report on Monday, December 22nd. Morgan Stanley reiterated an “equal weight” rating and set a $24.55 price objective (down from $27.00) on shares of Clearwater Analytics in a research note on Tuesday, January 27th. Finally, Oppenheimer downgraded shares of Clearwater Analytics from an “outperform” rating to a “market perform” rating in a research note on Monday, December 22nd. Three analysts have rated the stock with a Buy rating, ten have assigned a Hold rating and one has given a Sell rating to the stock. According to MarketBeat, Clearwater Analytics currently has an average rating of “Hold” and an average target price of $26.17.
View Our Latest Stock Analysis on Clearwater Analytics
Clearwater Analytics Price Performance Shares of NYSE CWAN opened at $23.80 on Monday. The company has a quick ratio of 1.83, a current ratio of 1.83 and a debt-to-equity ratio of 0.40. Clearwater Analytics Holdings, Inc. has a fifty-two week low of $15.73 and a fifty-two week high of $26.94. The business has a 50 day moving average price of $23.52 and a two-hundred day moving average price of $21.69. The firm has a market cap of $7.03 billion, a PE ratio of -169.95, a price-to-earnings-growth ratio of 3.31 and a beta of 0.64.
Clearwater Analytics Company Profile (Free Report)
Clearwater Analytics LLC is a global provider of web-based investment portfolio accounting, reporting, and analytics solutions. The company’s software-as-a-service platform automates complex processes involved in investment data aggregation, reconciliation, valuation, and regulatory reporting. Serving institutional investors—including insurers, asset managers, corporations, government entities, and asset owners—Clearwater Analytics enables clients to optimize performance visibility, risk management, and operational efficiency.
Founded in 2004 and headquartered in Boise, Idaho, Clearwater Analytics has grown its global footprint with offices across North America, Europe, and the Asia-Pacific region.
Read More Five stocks we like better than Clearwater Analytics Want to see what other hedge funds are holding CWAN? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Free Report).
Receive News & Ratings for Clearwater Analytics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Clearwater Analytics and related companies with MarketBeat.com's FREE daily email newsletter.
« PREVIOUS HEADLINEJPMorgan Chase & Co. Purchases 60,002 Shares of DAQO New Energy Corp. $DQ
NEXT HEADLINE »Capital Management Associates Inc Buys 4,899 Shares of Vanguard Financials ETF $VFH
Insiders may stand to receive substantial financial benefits not available to ordinary shareholders.
The proposed transactions may contain terms that could limit superior competing offers.
Shareholders are encouraged to contact the firm to discuss their rights and options at no cost or obligation. We would handle any matter on a contingent fee basis, whereby you would not be responsible for out-of-pocket payment of our legal fees or expenses.
, /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to:
Odyssey Marine Exploration, Inc. (NASDAQ: OMEX)'s merger with American Ocean Minerals Corporation. If you are an Odyssey shareholder, click here to learn more about your legal rights and options.
Penumbra, Inc. (NYSE: PEN)'s sale to Boston Scientific Corporation for $374.00 in cash or 3.8721 shares of Boston Scientific common stock. If you are a Penumbra shareholder, click here to learn more about your rights and options.
Sun Country Airlines Holdings, Inc. (NASDAQ: SNCY)'s sale to Allegiant Travel Company for 0.1557 shares of Allegiant common stock and $4.10 in cash for each Sun Country share. If you are a Sun Country shareholder, click here to learn more about your rights and options.
Clearwater Analytics Holdings, Inc. (NYSE: CWAN)'s sale to Permira and Warburg Pincus for $24.55 per share in cash. If you are a Clearwater shareholder, click here to learn more about your rights and options.
On behalf of shareholders, Halper Sadeh LLC may seek increased consideration, additional disclosures and information, or other relief and benefits.
Halper Sadeh LLC represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Halper Sadeh LLC
Daniel Sadeh, Esq.
Zachary Halper, Esq.
One World Trade Center
85th Floor
New York, NY 10007
(212) 763-0060
[email protected]
[email protected]
https://www.halpersadeh.com
NEW YORK & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Clearwater Analytics Holdings, Inc. (NYSE: CWAN) to Permira and Warburg Pincus. Under the terms of the proposed transaction, shareholders of Clearwater will receive $24.55 in cash for each share of Clearwater that they own. KSF is seeking to determine whether this consideration and the process that l.
Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Get Free Report) CTO Souvik Das sold 10,000 shares of the business’s stock in a transaction on Wednesday, April 8th. The stock was sold at an average price of $24.01, for a total transaction of $240,100.00. Following the completion of the sale, the chief technology officer directly owned 200,109 shares of the company’s stock, valued at approximately $4,804,617.09. The trade was a 4.76% decrease in their position. The sale was disclosed in a filing with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.
Souvik Das also recently made the following trade(s):
On Tuesday, March 31st, Souvik Das sold 14,686 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.80, for a total transaction of $349,526.80. On Monday, March 9th, Souvik Das sold 10,000 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.37, for a total transaction of $233,700.00. On Wednesday, February 18th, Souvik Das sold 88,848 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.44, for a total transaction of $2,082,597.12. On Monday, February 9th, Souvik Das sold 10,000 shares of Clearwater Analytics stock. The stock was sold at an average price of $23.89, for a total transaction of $238,900.00. Clearwater Analytics Price Performance Shares of NYSE CWAN opened at $24.05 on Wednesday. The firm has a market cap of $7.11 billion, a PE ratio of -171.77, a PEG ratio of 3.34 and a beta of 0.64. The firm has a fifty day moving average of $23.51 and a 200 day moving average of $21.97. The company has a debt-to-equity ratio of 0.40, a quick ratio of 1.83 and a current ratio of 1.83. Clearwater Analytics Holdings, Inc. has a one year low of $15.73 and a one year high of $25.07.
Wall Street Analysts Forecast Growth Several equities research analysts have issued reports on the stock. Weiss Ratings cut shares of Clearwater Analytics from a “hold (c)” rating to a “sell (d+)” rating in a research note on Monday, February 23rd. Wells Fargo & Company cut shares of Clearwater Analytics from an “overweight” rating to an “equal weight” rating and lowered their target price for the stock from $27.00 to $24.55 in a research note on Thursday, January 8th. Jefferies Financial Group cut shares of Clearwater Analytics to a “hold” rating in a research note on Friday, January 16th. DA Davidson reaffirmed a “neutral” rating and set a $24.55 target price on shares of Clearwater Analytics in a research note on Thursday, February 19th. Finally, Morgan Stanley reaffirmed an “equal weight” rating and set a $24.55 target price (down from $27.00) on shares of Clearwater Analytics in a research note on Tuesday, January 27th. Three research analysts have rated the stock with a Buy rating, ten have given a Hold rating and one has assigned a Sell rating to the stock. According to MarketBeat, Clearwater Analytics presently has a consensus rating of “Hold” and a consensus price target of $26.17.
Get Our Latest Report on CWAN
Institutional Trading of Clearwater Analytics Institutional investors and hedge funds have recently bought and sold shares of the stock. EverSource Wealth Advisors LLC raised its holdings in Clearwater Analytics by 211.1% in the 4th quarter. EverSource Wealth Advisors LLC now owns 1,061 shares of the company’s stock valued at $26,000 after buying an additional 720 shares during the period. Los Angeles Capital Management LLC purchased a new stake in Clearwater Analytics in the 4th quarter valued at about $26,000. SBI Securities Co. Ltd. raised its holdings in Clearwater Analytics by 627.5% in the 4th quarter. SBI Securities Co. Ltd. now owns 1,375 shares of the company’s stock valued at $33,000 after buying an additional 1,186 shares during the period. Caitong International Asset Management Co. Ltd purchased a new stake in Clearwater Analytics in the 4th quarter valued at about $33,000. Finally, Private Trust Co. NA raised its holdings in Clearwater Analytics by 643.3% in the 4th quarter. Private Trust Co. NA now owns 1,546 shares of the company’s stock valued at $37,000 after buying an additional 1,338 shares during the period. 50.10% of the stock is currently owned by hedge funds and other institutional investors.
About Clearwater Analytics (Get Free Report)
Clearwater Analytics LLC is a global provider of web-based investment portfolio accounting, reporting, and analytics solutions. The company’s software-as-a-service platform automates complex processes involved in investment data aggregation, reconciliation, valuation, and regulatory reporting. Serving institutional investors—including insurers, asset managers, corporations, government entities, and asset owners—Clearwater Analytics enables clients to optimize performance visibility, risk management, and operational efficiency.
Founded in 2004 and headquartered in Boise, Idaho, Clearwater Analytics has grown its global footprint with offices across North America, Europe, and the Asia-Pacific region.
Recommended Stories Five stocks we like better than Clearwater Analytics
Receive News & Ratings for Clearwater Analytics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Clearwater Analytics and related companies with MarketBeat.com's FREE daily email newsletter.
« PREVIOUS HEADLINEFermi (NASDAQ:FRMI) vs. JAN (NYSE:JAN) Critical Comparison
NEXT HEADLINE »IGM Financial Inc. (TSE:IGM) Receives Average Recommendation of “Hold” from Analysts
Special meeting of stockholders to be held on May 6, 2026Is the buyout price of $24.55 too low? PHILADELPHIA, April 16, 2026 (GLOBE NEWSWIRE) -- On April 8, 2026, Clearwater Analytics Holdings, Inc. (NYSE: CWAN) (“Clearwater”) reported that it has scheduled a special meeting of stockholders to be held on May 6, 2026, during which it will ask its investors to vote to approve the $24.55 per share stockholder buyout proposal.
As that meeting date has now been set, Kaskela Law alerts Clearwater shareholders that they now only have a limited period of time – prior to the special meeting of stockholders – to act if they wish to preserve their legal rights and options with respect to buyout transaction.
Click here to receive additional information about your rights: https://kaskelalaw.com/case/clearwater-analytics-buyout/
On December 21, 2025, Clearwater announced that it had agreed to be acquired by a group of private equity funds at a price of $24.55 per share. Following the closing of the proposed transaction, Clearwater shareholders will be cashed out of their investment position and the company’s shares will no longer be publicly traded.
Kaskela Law’s investigation has discovered that the transaction appears to have significant conflicts of interest, thus making the sales process and proposed $24.55 per share price unfair to Clearwater shareholders. Notably, at the time the transaction was announced, several analysts were maintaining price targets for Clearwater shares of over $35.00 per share.
“We are investigating this transaction and encourage Clearwater shareholders who think the buyout price is too low to promptly contact Kaskela Law to preserve their legal rights before the special meeting of stockholders” said attorney D. Seamus Kaskela, who is leading the firm’s investigation.
Clearwater shareholders are encouraged to promptly contact Kaskela Law (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by email at [email protected], to preserve their legal rights and options. Investors may also request additional information about this matter by clicking on the following link (or by copying and pasting the link into your browser if necessary):
Kaskela Law exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis. For additional information about the firm, including the firm’s recent monetary recoveries for investors in mergers & acquisition litigation, please visit our website (www.kaskelalaw.com) or contact us today at (888) 715 – 1740.
KASKELA LAW LLC
D. Seamus Kaskela, Esquire
Adrienne Bell, Esquire
18 Campus Boulevard, Suite 100
Newtown Square, PA 19073
(484) 229 – 0750
www.kaskelalaw.com
This communication may constitute attorney advertising in certain jurisdictions.
NEW YORK--(BUSINESS WIRE)---- $CWAN #NYSE--Scott+Scott Attorneys at Law LLP has launched an urgent investigation into whether the directors of Clearwater Analytics Holdings, Inc. (NYSE: CWAN) breached their fiduciary duties to Clearwater's shareholders in approving a buyout by Warburg Pincus LLC and Permira Advisers LLC. Attorney Joseph A. Pettigrew is heading the investigation—what shareholders need to know:On December 20, 2025, Clearwater announced it had entered into an agreement to be bought out by an inves.
Philadelphia, Pennsylvania--(Newsfile Corp. - April 18, 2026) - On April 8, 2026, Clearwater Analytics Holdings, Inc. (NYSE: CWAN) ("Clearwater") reported that it has scheduled a special meeting of stockholders to be held on May 6, 2026, during which it will ask its investors to vote to approve the $24.55 per share stockholder buyout proposal.
As that meeting date has now been set, Kaskela Law alerts Clearwater shareholders that they now only have a limited period of time – prior to the special meeting of stockholders – to act if they wish to preserve their legal rights and options with respect to buyout transaction.
Click here to receive additional information about your rights: https://kaskelalaw.com/case/clearwater-analytics-buyout/
On December 21, 2025, Clearwater announced that it had agreed to be acquired by a group of private equity funds at a price of $24.55 per share. Following the closing of the proposed transaction, Clearwater shareholders will be cashed out of their investment position and the company's shares will no longer be publicly traded.
Kaskela Law's investigation has discovered that the transaction appears to have significant conflicts of interest, thus making the sales process and proposed $24.55 per share price unfair to Clearwater shareholders. Notably, at the time the transaction was announced, several analysts were maintaining price targets for Clearwater shares of over $35.00 per share.
Clearwater shareholders who would like to learn more about the investigation and their legal rights and options are encouraged to contact lead investigative attorney Adrienne Bell, Esq. at (484) 229 - 0750, by email at [email protected], or by filling out our online form at:
Kaskela Law exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation on a contingent basis. For additional information about the firm, including our recent monetary recoveries for investors, please visit our website (www.kaskelalaw.com) or contact us today at (888) 715 - 1740.
KASKELA LAW LLC
D. Seamus Kaskela, Esquire
Adrienne Bell, Esquire
18 Campus Boulevard, Suite 100
Newtown Square, PA 19073
(484) 229 - 0750
www.kaskelalaw.com
This communication may constitute attorney advertising in certain jurisdictions.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/293201
Source: Kaskela Law LLC
Ready to Announce with Confidence? Send us a message and a member of our TMX Newsfile team will contact you to discuss your needs.
Clearwater Analytics Holdings, Inc. (NYSE:CWAN – Get Free Report) CFO James Cox sold 18,700 shares of the business’s stock in a transaction on Wednesday, April 15th. The stock was sold at an average price of $24.07, for a total value of $450,109.00. Following the completion of the transaction, the chief financial officer directly owned 480,419 shares in the company, valued at approximately $11,563,685.33. This represents a 3.75% decrease in their position. The transaction was disclosed in a filing with the SEC, which is accessible through this hyperlink. The sale was made to cover tax withholding obligations related to the vesting of equity awards.
Clearwater Analytics Price Performance Clearwater Analytics stock opened at $24.10 on Friday. The company has a debt-to-equity ratio of 0.40, a quick ratio of 1.83 and a current ratio of 1.83. The firm has a market cap of $7.12 billion, a P/E ratio of -172.13, a P/E/G ratio of 3.35 and a beta of 0.64. The business’s fifty day moving average is $23.54 and its two-hundred day moving average is $22.06. Clearwater Analytics Holdings, Inc. has a 52 week low of $15.73 and a 52 week high of $25.07.
Institutional Investors Weigh In On Clearwater Analytics A number of institutional investors and hedge funds have recently added to or reduced their stakes in the stock. Rockefeller Capital Management L.P. increased its holdings in Clearwater Analytics by 28.3% in the fourth quarter. Rockefeller Capital Management L.P. now owns 44,848 shares of the company’s stock valued at $1,082,000 after purchasing an additional 9,890 shares during the last quarter. Larry Mathis Financial Planning LLC bought a new stake in Clearwater Analytics in the fourth quarter valued at about $228,000. Ovata Capital Management Ltd bought a new stake in shares of Clearwater Analytics in the fourth quarter worth about $6,811,000. Alberta Investment Management Corp bought a new stake in shares of Clearwater Analytics in the fourth quarter worth about $13,850,000. Finally, Mercer Global Advisors Inc. ADV bought a new stake in shares of Clearwater Analytics in the fourth quarter worth about $400,000. Institutional investors own 50.10% of the company’s stock.
Wall Street Analyst Weigh In CWAN has been the subject of a number of recent research reports. DA Davidson restated a “neutral” rating and set a $24.55 target price on shares of Clearwater Analytics in a research report on Thursday, February 19th. UBS Group downgraded Clearwater Analytics from a “buy” rating to a “neutral” rating and dropped their target price for the stock from $30.00 to $24.55 in a research report on Monday, January 26th. Oppenheimer downgraded Clearwater Analytics from an “outperform” rating to a “market perform” rating in a research report on Monday, December 22nd. Loop Capital downgraded Clearwater Analytics from a “buy” rating to a “hold” rating and dropped their target price for the stock from $25.00 to $24.55 in a research report on Monday, December 22nd. Finally, Warburg Research set a $24.55 target price on Clearwater Analytics in a research report on Monday, December 22nd. Three equities research analysts have rated the stock with a Buy rating, ten have given a Hold rating and one has issued a Sell rating to the company’s stock. According to data from MarketBeat, Clearwater Analytics currently has a consensus rating of “Hold” and a consensus price target of $26.17.
View Our Latest Report on Clearwater Analytics
About Clearwater Analytics (Get Free Report)
Clearwater Analytics LLC is a global provider of web-based investment portfolio accounting, reporting, and analytics solutions. The company’s software-as-a-service platform automates complex processes involved in investment data aggregation, reconciliation, valuation, and regulatory reporting. Serving institutional investors—including insurers, asset managers, corporations, government entities, and asset owners—Clearwater Analytics enables clients to optimize performance visibility, risk management, and operational efficiency.
Founded in 2004 and headquartered in Boise, Idaho, Clearwater Analytics has grown its global footprint with offices across North America, Europe, and the Asia-Pacific region.
See Also Five stocks we like better than Clearwater Analytics
Receive News & Ratings for Clearwater Analytics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Clearwater Analytics and related companies with MarketBeat.com's FREE daily email newsletter.
HONG KONG, SINGAPORE & SYDNEY--(BUSINESS WIRE)--Insurance executives across Asia Pacific are accelerating into private markets. Within five years, the 150 executives surveyed by Clearwater Analytics (NYSE: CWAN) expect to allocate a third of their combined $3.8 trillion in assets to private debt, private equity, infrastructure and other alternatives up from 20% today. The infrastructure supporting these ambitions, however, is not keeping pace. Ninety-three percent of those same executives ackno.
BOISE, Idaho--(BUSINESS WIRE)--Clearwater Analytics Holdings, Inc. (NYSE: CWAN), (“CWAN” or the “Company”), the most comprehensive technology platform for investment management, will release financial results for the first quarter ended March 31, 2026 after the U.S. financial markets close on Thursday, May 7, 2026. As a result of the execution of a definitive agreement (the “Merger Agreement”) pursuant to which an investor group led by Permira and Warburg Pincus will acquire all of the outstand.
Wall Street analysts expect Clearwater Analytics (CWAN - Free Report) to post quarterly earnings of $0.16 per share in its upcoming report, which indicates a year-over-year increase of 23.1%. Revenues are expected to be $222.99 million, up 75.8% from the year-ago quarter.
The current level reflects no revision in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their initial projections over this period.
Prior to a company's earnings release, it is of utmost importance to factor in any revisions made to the earnings projections. These revisions serve as a critical gauge for predicting potential investor behaviors with respect to the stock. Empirical studies consistently reveal a strong link between trends in earnings estimate revisions and the short-term price performance of a stock.
While investors typically rely on consensus earnings and revenue estimates to gauge how the business may have fared during the quarter, examining analysts' projections for some of the company's key metrics often helps gain a deeper insight.
That said, let's delve into the average estimates of some Clearwater Analytics metrics that Wall Street analysts commonly model and monitor.
The combined assessment of analysts suggests that 'Number of Clients' will likely reach 2,602 . Compared to the current estimate, the company reported 1,400 in the same quarter of the previous year.
Analysts' assessment points toward 'Net revenue retention rate' reaching 109.7%. Compared to the current estimate, the company reported 114.0% in the same quarter of the previous year.
The average prediction of analysts places 'Total ARR' at $865.66 million. The estimate is in contrast to the year-ago figure of $493.90 million.
View all Key Company Metrics for Clearwater Analytics here>>>
Clearwater Analytics shares have witnessed a change of +1.1% in the past month, in contrast to the Zacks S&P 500 composite's +10.3% move. With a Zacks Rank #3 (Hold), CWAN is expected closely follow the overall market performance in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .
BOISE, Idaho--(BUSINESS WIRE)--Clearwater Analytics Holdings, Inc. (NYSE: CWAN) (“CWAN” or the “Company”), the most comprehensive technology platform for investment management, today announced its financial results for the quarter ended March 31, 2026. “We delivered a strong start to 2026 with Q1 revenue of $221.2 million, up 74% year-over-year. GenAI tools are woven into the fabric of our organization, enabling both technical and non-technical employees to deliver internal automation and new p.
Clearwater Analytics (CWAN - Free Report) came out with quarterly earnings of $0.16 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.13 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of -2.44%. A quarter ago, it was expected that this automated investment accounting software developer would post earnings of $0.15 per share when it actually produced earnings of $0.15, delivering no surprise.
Over the last four quarters, the company has not been able to surpass consensus EPS estimates.
Clearwater Analytics, which belongs to the Zacks Internet - Software industry, posted revenues of $221.23 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 0.79%. This compares to year-ago revenues of $126.86 million. The company has topped consensus revenue estimates three times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Clearwater Analytics shares have added about 0.6% since the beginning of the year versus the S&P 500's gain of 7.6%.
What's Next for Clearwater Analytics?While Clearwater Analytics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Clearwater Analytics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.17 on $232.66 million in revenues for the coming quarter and $0.70 on $949.6 million in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Internet - Software is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
One other stock from the same industry, PagerDuty (PD - Free Report) , is yet to report results for the quarter ended April 2026.
This software developer is expected to post quarterly earnings of $0.24 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
PagerDuty's revenues are expected to be $119.18 million, down 0.5% from the year-ago quarter.
BOISE, Idaho & NEW YORK & CHICAGO & LONDON & HONG KONG--(BUSINESS WIRE)--Clearwater Analytics (NYSE: CWAN) today released the 2026 Insurance Investment Outsourcing Report (IIOR), produced in partnership with DCS Financial Consulting. The report captures $5.5 trillion in third-party general account insurance assets under management across 96 asset managers, a 23% increase year-over-year and a 65% increase since 2021, alongside $1.8 trillion in assets under advisement across 12 investment consult.
Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a great growth stock is not easy at all.
By their very nature, these stocks carry above-average risk and volatility. Moreover, if a company's growth story is over or nearing its end, betting on it could lead to significant loss.
However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Growth Style Score (part of the Zacks Style Scores system), which looks beyond the traditional growth attributes to analyze a company's real growth prospects.
Clearwater Analytics (CWAN - Free Report) is on the list of such stocks currently recommended by our proprietary system. In addition to a favorable Growth Score, it carries a top Zacks Rank.
Research shows that stocks carrying the best growth features consistently beat the market. And returns are even better for stocks that possess the combination of a Growth Score of A or B and a Zacks Rank #1 (Strong Buy) or 2 (Buy).
While there are numerous reasons why the stock of this automated investment accounting software developer is a great growth pick right now, we have highlighted three of the most important factors below:
Earnings GrowthArguably nothing is more important than earnings growth, as surging profit levels is what most investors are after. For growth investors, double-digit earnings growth is highly preferable, as it is often perceived as an indication of strong prospects (and stock price gains) for the company under consideration.
While the historical EPS growth rate for Clearwater Analytics is 120.3%, investors should actually focus on the projected growth. The company's EPS is expected to grow 28.1% this year, crushing the industry average, which calls for EPS growth of 23.8%.
Cash Flow GrowthWhile cash is the lifeblood of any business, higher-than-average cash flow growth is more important and beneficial for growth-oriented companies than for mature companies. That's because, growth in cash flow enables these companies to expand their businesses without depending on expensive outside funds.
Right now, year-over-year cash flow growth for Clearwater Analytics is 243.2%, which is higher than many of its peers. In fact, the rate compares to the industry average of 6.9%.
While investors should actually consider the current cash flow growth, it's worth taking a look at the historical rate too for putting the current reading into proper perspective. The company's annualized cash flow growth rate has been 43.5% over the past 3-5 years versus the industry average of 17%.
Promising Earnings Estimate RevisionsSuperiority of a stock in terms of the metrics outlined above can be further validated by looking at the trend in earnings estimate revisions. A positive trend is of course favorable here. Empirical research shows that there is a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
There have been upward revisions in current-year earnings estimates for Clearwater Analytics. The Zacks Consensus Estimate for the current year has surged 2.1% over the past month.
Bottom LineWhile the overall earnings estimate revisions have made Clearwater Analytics a Zacks Rank #2 stock, it has earned itself a Growth Score of B based on a number of factors, including the ones discussed above.
You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
This combination positions Clearwater Analytics well for outperformance, so growth investors may want to bet on it.
BOISE, Idaho & NEW YORK & CHICAGO & LONDON & HONG KONG--(BUSINESS WIRE)--Clearwater Analytics (NYSE: CWAN) today introduced new AI-enabled products built on the same trusted investment data foundation supporting more than $10 trillion in global assets. The new products extend Clearwater's platform across operations, risk, and private markets workflows, helping institutional investors move faster without sacrificing transparency, control, or auditability. “Every firm in this industry wants AI th.
Clearwater Analytics (NYSE: CWAN) today introduced new AI-enabled products built on the same trusted investment data foundation supporting more than $10 trillion in global assets.
The new products extend Clearwater’s platform across operations, risk, and private markets workflows, helping institutional investors move faster without sacrificing transparency, control, or auditability.
“Every firm in this industry wants AI that works,” said Sandeep Sahai, Chief Executive Officer at Clearwater Analytics. “What firms are discovering is that AI is only as good as the data it runs on. Clearwater was built around a trusted investment record. That allows firms to bring AI directly into the workflows that drive investment operations, risk, and portfolio oversight.”
The announcement includes three new products: Clearwater Compass, Total Portfolio Oversight, and Fund Analytics.
Clearwater Compass
AI for Investment Operations and Accounting
Clearwater Compass embeds AI into investment operations and accounting workflows, helping teams automate exception management, improve reconciliation transparency, and accelerate close processes with full auditability.
The first Compass capabilities available today are Smart Suspense and Recon Transparency.
Smart Suspense automates the matching and categorization of unapplied cash, replacing spreadsheet-driven workflows with a centralized operational workspace and complete audit visibility. Recon Transparency gives clients live visibility into reconciliation breaks Clearwater processes on their behalf, including source files, resolution status, root-cause analysis, and collaborative workflows that replace manual email chains. “When reconciliations, exceptions, and close workflows are connected directly to the investment record, firms can move faster while maintaining the controls institutional investors expect,” said Lisa Widdowson, Head of Product, Insurance and Asset Owners at Clearwater Analytics.
Total Portfolio Oversight
One View Across Investment and Risk
Developed with Blackstone and now live in production, Total Portfolio Oversight brings investment and risk teams together on a shared view spanning public and private assets. The solution combines portfolio oversight, risk exposure, shock analysis, and direct portfolio query capabilities in one experience, all connected to the same trusted investment record. Total Portfolio Oversight is currently being expanded to a select group of institutional beta clients.
Fund Analytics
Bringing Structure to Private Markets Data
Fund Analytics extends Clearwater’s platform into private markets, where investment teams still rely heavily on fragmented GP reports, capital statements, PDFs, spreadsheets, and manual processes.
The solution uses AI to extract, validate, and structure private markets data across funds, exposures, and performance metrics. Investment teams gain earlier visibility into portfolio changes, look-through exposure, peer benchmarking, and scenario analysis, all connected to the same trusted investment record used across the broader Clearwater platform.
Together, these products extend Clearwater’s investment platform across operations, risk, and private markets, helping institutional investors move faster with trusted data and embedded intelligence.
To learn more, visit Clearwater Analytics.
About CWAN
Clearwater Analytics (NYSE: CWAN) is transforming investment management with the industry’s most comprehensive cloud-native platform for institutional investors across global public and private markets. While legacy systems create risk, inefficiency, and data fragmentation, CWAN’s single-instance, multi-tenant architecture delivers real-time data and AI-driven insights throughout the investment lifecycle. The platform eliminates information silos by integrating portfolio management, trading, investment accounting, reconciliation, regulatory reporting, performance, compliance, and risk analytics in one unified system. Serving leading insurers, asset managers, hedge funds, banks, corporations, and governments, CWAN supports over $10 trillion in assets globally.Learn more at www.cwan.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260603752616/en/
BOISE, Idaho & NEW YORK & CHICAGO & LONDON & HONG KONG--(BUSINESS WIRE)--Clearwater Analytics (NYSE: CWAN) today announced new factor risk capabilities for hedge funds and asset managers, helping investment teams make faster decisions with greater visibility into portfolio risk. For many firms, factor risk remains disconnected from the investment process. Portfolio managers often wait hours or until the next day to understand the risk implications of a trade, while Chief Investment Officers (CI.
ArrowMark Colorado Holdings LLC lowered its holdings in Legend Biotech Corporation Sponsored ADR (NASDAQ: LEGN) by 4.6% during the third quarter, according to its most recent filing with the Securities and Exchange Commission. The fund owned 938,678 shares of the company's stock after selling 44,832 shares during the quarter. ArrowMark Colorado Holdings LLC
Legend Biotech Corporation Sponsored ADR (NASDAQ:LEGN – Get Free Report) has been assigned an average rating of “Moderate Buy” from the fifteen research firms that are presently covering the company, Marketbeat reports. One equities research analyst has rated the stock with a sell rating, three have issued a hold rating and eleven have given a buy rating to the company. The average 12-month price target among brokerages that have issued a report on the stock in the last year is $58.3077.
A number of equities research analysts have weighed in on LEGN shares. Morgan Stanley decreased their price target on shares of Legend Biotech from $50.00 to $49.00 and set an “overweight” rating on the stock in a research note on Wednesday, March 11th. UBS Group reduced their price objective on shares of Legend Biotech from $54.00 to $48.00 and set a “buy” rating for the company in a report on Monday, December 8th. Cantor Fitzgerald decreased their target price on shares of Legend Biotech from $75.00 to $74.00 and set an “overweight” rating on the stock in a research report on Wednesday, December 17th. Jefferies Financial Group reissued a “buy” rating and issued a $69.00 price target on shares of Legend Biotech in a research report on Tuesday, March 10th. Finally, Oppenheimer assumed coverage on shares of Legend Biotech in a research note on Wednesday, January 7th. They set an “outperform” rating and a $75.00 price target for the company.
View Our Latest Analysis on LEGN
Legend Biotech Price Performance Legend Biotech stock opened at $19.14 on Friday. The business has a 50 day moving average price of $18.19 and a two-hundred day moving average price of $24.55. Legend Biotech has a 12 month low of $16.24 and a 12 month high of $45.30. The stock has a market cap of $3.54 billion, a price-to-earnings ratio of -23.93 and a beta of 0.08.
Legend Biotech (NASDAQ:LEGN – Get Free Report) last released its quarterly earnings data on Wednesday, March 11th. The company reported $0.01 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of ($0.17) by $0.18. The business had revenue of $306.30 million for the quarter, compared to analysts’ expectations of $310.21 million. Legend Biotech had a negative return on equity of 21.93% and a negative net margin of 28.86%.Legend Biotech’s quarterly revenue was up 64.2% on a year-over-year basis. During the same period in the previous year, the business posted $0.07 earnings per share. On average, analysts expect that Legend Biotech will post -1.31 earnings per share for the current fiscal year.
Insider Activity at Legend Biotech In related news, CEO Ying Huang sold 9,936 shares of the firm’s stock in a transaction that occurred on Wednesday, March 25th. The stock was sold at an average price of $8.77, for a total transaction of $87,138.72. Following the completion of the transaction, the chief executive officer owned 247,438 shares in the company, valued at $2,170,031.26. This trade represents a 3.86% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available through the SEC website. 0.02% of the stock is owned by company insiders.
Institutional Inflows and Outflows Hedge funds have recently bought and sold shares of the stock. Clearstead Advisors LLC boosted its stake in shares of Legend Biotech by 76.5% in the 3rd quarter. Clearstead Advisors LLC now owns 847 shares of the company’s stock valued at $28,000 after purchasing an additional 367 shares in the last quarter. Parallel Advisors LLC grew its holdings in shares of Legend Biotech by 171.9% in the 3rd quarter. Parallel Advisors LLC now owns 1,047 shares of the company’s stock worth $34,000 after purchasing an additional 662 shares during the last quarter. OFI Invest Asset Management increased its position in shares of Legend Biotech by 102.6% during the 3rd quarter. OFI Invest Asset Management now owns 1,228 shares of the company’s stock worth $40,000 after purchasing an additional 622 shares in the last quarter. Raymond James Financial Inc. bought a new position in Legend Biotech during the 2nd quarter valued at about $78,000. Finally, Harvest Fund Management Co. Ltd bought a new position in Legend Biotech during the 3rd quarter valued at about $104,000. 70.89% of the stock is currently owned by institutional investors and hedge funds.
About Legend Biotech (Get Free Report)
Legend Biotech (NASDAQ: LEGN) is a commercial-stage biopharmaceutical company specializing in the development and commercialization of chimeric antigen receptor T-cell (CAR-T) therapies for oncology. Headquartered in Somerset, New Jersey, with research and development operations in Shanghai, the company leverages a global infrastructure to advance innovative cellular therapies. Legend Biotech pursues a strategy of strategic collaboration to extend its reach, most notably through its partnership with Janssen Biotech, a subsidiary of Johnson & Johnson.
The company’s lead asset, ciltacabtagene autoleucel (commercially marketed as Carvykti), is a B-cell maturation antigen (BCMA)–directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma.
Featured Stories Five stocks we like better than Legend Biotech
Receive News & Ratings for Legend Biotech Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Legend Biotech and related companies with MarketBeat.com's FREE daily email newsletter.
« PREVIOUS HEADLINESG Americas Securities LLC Buys 18,420 Shares of Landstar System, Inc. $LSTR
NEXT HEADLINE »SG Americas Securities LLC Acquires 69,215 Shares of ARK Genomic Revolution ETF $ARKG
Legend Biotech (LEGN +4.07%) was one of the healthier healthcare stocks on the market as the trading week kicked off on Monday. Not one, but two, bullish analyst updates helped propel the biotech stock to a sturdy 18% gain on Monday, a performance that sharply contrasted with the 0.2% slump of the S&P 500 index.
A pharmaceutical giant swoops That morning, both H.C. Wainwright's Mitchell Kapoor and RBC Capital's Leonid Timashev reiterated their equivalents of buy recommendations on Legend. Of the pair, Timashev is the more bullish, as his price target is $62 per share, while Kapoor's is $50.
Image source: Getty Images.
According to reports, the RBC prognosticator was inspired by Eli Lilly's announcement early Monday that it is buying clinical-stage oncology drug developer Kelonia Therapeutics in a deal potentially worth up to $7 billion. Like Kelonia, Legend harnesses chimeric antigen receptor T-cell therapy (CAR-T) in its investigational drugs.
As for H.C. Wainwright's Kapoor, according to reports, he waxed bullish in his update about the generally encouraging progress of all Legend pipeline programs. He noted that data from an early stage in vivo trial of the company's CD19/CD20 should be published in the near future. If successful, this form of therapy could hold great promise for the treatment of certain cancers.
Today's Change
(
4.07
%) $
1.42
Current Price
$
36.28
Potentially legendary It's understandable that, as Timashev pointed out, the Eli Lilly/Kelonia deal sparked excitement about Legend's future. For once, though, this isn't just hope or hype -- Legend has innovative, very promising science supporting its pipeline programs. This is absolutely a biotech to watch, in my view, purely on the strength of those programs.
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool recommends Legend Biotech. The Motley Fool has a disclosure policy.
Legend Biotech Corporation Sponsored ADR (LEGN - Free Report) shares ended the last trading session 18.4% higher at $25.07. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 21.6% gain over the past four weeks.
The sudden rise in the stock price is likely fueled by investor optimism over the continued strong sales of Carvykti, Legend Biotech’s one-time therapy for relapsed or refractory multiple myeloma, developed and marketed in partnership with Johnson & Johnson. The company has a broad clinical pipeline comprising several oncology candidates being developed across various stages.
This company is expected to post quarterly loss of $0.02 per share in its upcoming report, which represents a year-over-year change of +71.4%. Revenues are expected to be $308.38 million, up 58.1% from the year-ago quarter.
While earnings and revenue growth expectations are important in evaluating the potential strength in a stock, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
For Legend Biotech, the consensus EPS estimate for the quarter has been revised 17.5% lower over the last 30 days to the current level. And a negative trend in earnings estimate revisions doesn't usually translate into price appreciation. So, make sure to keep an eye on LEGN going forward to see if this recent jump can turn into more strength down the road.
The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
Legend Biotech belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Harmony Biosciences Holdings, Inc. (HRMY - Free Report) , closed the last trading session 1.5% lower at $29.53. Over the past month, HRMY has returned 8.2%.
Harmony Biosciences' consensus EPS estimate for the upcoming report has remained unchanged over the past month at $0.76. Compared to the company's year-ago EPS, this represents a change of -2.6%. Harmony Biosciences currently boasts a Zacks Rank of #5 (Strong Sell).
In my opinion, Legend Biotech Corporation is an attractive acquisition target for Johnson & Johnson. Carvykti, which they are jointly developing, is quickly catching up in sales with Darzalex, J&J's blockbuster for the treatment of multiple myeloma. So, sales of Carvykti reached $597 million in Q1, up 61.8% year-on-year, beating my 'best case' scenario by $15 million.
April 28, 2026 08:00 ET | Source: Legend Biotech USA Inc.
SOMERSET, N.J., April 28, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will host a conference call for investors at 8:00 am ET on Tuesday, May 12, 2026, to review first quarter 2026 financial results.
During the conference call and accompanying webcast, senior management will provide an overview of quarterly financial performance.
Investors and other interested parties may access the live audio webcast via this weblink.
A replay of the webcast, along with the earnings press release, will be available in the Investor Relations section of the Legend Biotech website under Events and Presentation approximately two hours after the conclusion of the call.
ABOUT LEGEND BIOTECH
With over 2,900 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at www.legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn.
Leading experts across cell therapy, oncology, and immunology will provide strategic input as Legend advances and expands beyond its current portfolio May 04, 2026 08:00 ET | Source: Legend Biotech USA Inc.
SOMERSET, N.J., May 04, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced the engagement with a group of distinguished scientific advisors who will provide strategic input as Legend advances its pipeline and future research priorities.
The advisors, who include Renier Brentjens, M.D., Ph.D., Spencer Fisk, Carl June, M.D., Maximilian F. Konig, M.D., Anthony Polverino, Ph.D., and Georg Schett, M.D., bring deep expertise spanning oncology, immunology, development, and manufacturing of cell-based therapies.
“These advisors bring an exceptional breadth of experience that will help guide our scientific priorities and identify new opportunities for innovation,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “As we look to advance and expand beyond our current portfolio, their perspectives will help shape our long-term scientific direction as we build a diversified, next-generation cell therapy pipeline focused on areas of high unmet need.”
Through ongoing engagement, these advisors will contribute their perspectives across emerging science, translational research, clinical development, and manufacturing priorities, including the identification of future areas of unmet need.
Collectively, these advisors reinforce the evolution of Legend Biotech as an end-to-end cell therapy company and the advancement of a next-generation pipeline with the potential to expand patient access and unlock new therapeutic possibilities.
About the Advisors
Renier Brentjens, M.D., Ph.D. – A pioneer in CAR-T cell therapy, Dr. Brentjens serves as Deputy Director and Chair of the Department of Medicine at Roswell Park Comprehensive Cancer Center. He pioneered the early clinical development of CD19-directed CAR-T cell therapies, developed armored CAR-T cells to overcome the tumor microenvironment, and is actively exploring preclinical and clinical work advancing CAR-Ts against solid tumor antigens. Recently, Dr. Brentjens was named a recipient of the Warren Alpert Foundation Prize for his pioneering applications of CAR-T cell therapy.Spencer Fisk – A seasoned CMC and technical operations leader, Mr. Fisk currently serves as Chief Technology & Quality Officer at Ottimo Pharma. At Novartis, he initiated CMC development and later led the manufacturing readiness for the approval and global commercial launch of the first FDA-approved CAR-T cell therapy for acute lymphoblastic leukemia (ALL). He brings more than 35 years of industry experience from Merck, Genentech, and other leading and innovative biopharmaceutical organizations.Carl June, M.D. – A globally recognized immunologist and pioneer of CAR-T therapy, Dr. June led the development of the first U.S. Food and Drug Administration (FDA)-approved CAR-T therapy and co-founded several biotech companies. He is Director of the Center for Cellular Immunotherapies at the University of Pennsylvania and Director of the Parker Institute for Cancer Immunotherapy. Dr. June’s lab studies various mechanisms of lymphocyte activation related to immune tolerance and adoptive immunotherapy for cancer and chronic infection.Maximilian F. Konig, M.D. – A physician-scientist, Director of the Cellular Therapy Program (Autoimmunity), and Co-Director of the Center for Autoimmunity and Immuno-Oncology at Johns Hopkins University, Dr. Konig specializes in rheumatology and immunology. His lab pioneers the development of antigen-specific and precision immunotherapy platforms for autoimmune diseases. He is also the scientific co-founder of Winnow Therapeutics.Anthony Polverino, Ph.D. – A veteran R&D leader in oncology and immunology, Dr. Polverino previously served as Chief Scientific Officer at Zymeworks and Kite Pharma, where he contributed to the approval of a CD19-targeted CAR-T cell therapy. He brings more than two decades of research leadership experience from Amgen and other biopharmaceutical organizations.Georg Schett, M.D. – A leading rheumatologist and immunologist, Dr. Schett serves as Professor of Internal Medicine, Head of the Department of Medicine 3 - Rheumatology and Immunology at Uniklinikum Erlangen and Vice President of Research at Friedrich-Alexander-Universität Erlangen-Nürnberg. He pioneered the application of CD19-directed CAR-T therapy in autoimmune diseases, including early clinical studies demonstrating drug-free remission in patients with severe lupus. About Legend Biotech
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI® patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X and LinkedIn.
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives, and the advancement of its pipeline and product portfolio. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
May 12, 2026 07:00 ET | Source: Legend Biotech USA Inc.
CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales increased 62% versus first quarter of 2025 to approximately $597 millionCARVYKTI® now available across 18 global markets, following recent launches in Italy, Poland, the Czech Republic, and AustraliaAdvanced early-stage cell therapy portfolio, with multiple data presentations expected at medical conferences in 2026Cash and cash equivalents, and time deposits of $834.6 million, as of March 31, 2026. SOMERSET, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its first quarter 2026 unaudited financial results and key corporate highlights.
“We believe CARVYKTI’s continued adoption and strong year‑over‑year growth reinforce our leadership in BCMA CAR‑T and the strength of our underlying operating model,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “As scale continues to build, we are seeing operating leverage translate into improving margins, supporting our path toward sustainable profitability. This continued progress is enabling us to advance our broad pipeline of cell therapy programs and extend the impact of our platform to address unmet needs for patients across multiple indications.”
Key Business Developments
Compared to the first quarter of 2025, CARVYKTI® net trade sales increased 62% in the first quarter of 2026 to approximately $597 million, with U.S. net trade sales growth of 36% and ex-U.S. net trade sales growth of 222%.Launched CARVYKTI® in Italy, Poland, the Czech Republic, and Australia, bringing availability to more than 300 global sites and 18 global markets.Continued to optimize CARVYKTI® manufacturing capabilities, including increasing manufacturing success rate to 99%, decreasing turnaround time, and delivering over 95% on-time order releases for final product delivery date during the first quarter of 2026.Advanced early-stage cell therapy portfolio, with multiple data presentations expected at medical conferences in 2026.In April 2026, achieved milestones totaling $55 million in connection with the Janssen Agreement (as defined below).Cash and cash equivalents, and time deposits of $834.6 million as of March 31, 2026, which Legend Biotech believes will provide financial runway beyond 2026, when Legend Biotech believes it will achieve a company-wide profit1. First Quarter 2026 Financial Results
Cash Position: Cash and cash equivalents, and time deposits were $834.6 million as of March 31, 2026.
Collaboration Revenue: Collaboration revenue was $298.4 million for the three months ended March 31, 2026, compared to $185.6 million for the three months ended March 31, 2025. The increase of $112.8 million was due to an increase in revenue generated from sales of CARVYKTI® in connection with the Janssen collaboration and license agreement (the “Janssen Agreement”).
License and Other Revenue: License revenue was $6.7 million for the three months ended March 31, 2026, compared to $9.4 million for the three months ended March 31, 2025. The decrease of $2.7 million was primarily attributed to revenue recognized under the license agreement with Novartis Pharma AG, which was recognized over time as Legend Biotech conducts a Phase 1 clinical trial for LB2102.
Cost of Collaboration Revenue: Cost of collaboration revenue was $175.4 million for the three months ended March 31, 2026, compared to $69.5 million for the three months ended March 31, 2025. The increase of $105.9 million was primarily due to Legend Biotech’s share of the cost of sales in connection with CARVYKTI® sales under the Janssen Agreement, as well as one-time additional costs incurred for capacity expansion and depreciation charges.
Research and Development Expenses: Research and development expenses were $85.7 million for the three months ended March 31, 2026, compared to $101.9 million for the three months ended March 31, 2025. The decrease of $16.2 million was primarily driven by lower expenditures in the cilta-cel clinical program as the patient dosing phases of major trials concluded, partially offset by higher pipeline-related research and development activities.
Administrative Expenses: Administrative expenses were $40.0 million for the three months ended March 31, 2026, compared to $31.5 million for the three months ended March 31, 2025. The increase of $8.5 million was primarily driven by higher professional fees.
Selling and Distribution Expenses: Selling and distribution expenses were $50.1 million for the three months ended March 31, 2026, compared to $41.0 million for the three months ended March 31, 2025. The increase of $9.1 million was primarily due to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which rose with collaboration revenue.
Operating loss: Operating loss for the three months ended March 31, 2026, was $49.8 million compared to $51.7 million for the three months ended March 31, 2025. The year-over-year improvement of $1.9 million was primarily due to higher gross profit from CARVYKTI®.
Net Loss: Net loss was $54.3 million for the three months ended March 31, 2026, compared to a net loss of $101.0 million for the three months ended March 31, 2025. The year-over-year improvement of $46.7 million was primarily driven by lower unrealized foreign currency exchange losses compared to the prior period, as well as improved operating performance reflecting higher gross profit from CARVYKTI®.
Adjusted Net Loss: Adjusted net loss was $10.5 million for the three months ended March 31, 2026, compared to an adjusted net loss of $27.0 million for the three months ended March 31, 2025. The year-over-year improvement of $16.5 million was primarily driven by improved operating performance, reflecting higher gross profit from CARVYKTI®.
_____________________
1 Company-wide profit defined as Adjusted Net Income
Webcast/Conference Call Details:
Legend Biotech will host its quarterly earnings call and webcast today at 8:00 am ET. To access the webcast, please visit this weblink.
A replay of the webcast will be available on Legend Biotech’s website at https://investors.legendbiotech.com/events-and-presentations.
About Legend Biotech
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X and LinkedIn.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to the expected timing of initiation, completion, and results and data of Legend Biotech’s early-stage cell therapy portfolio; statements relating to the expected timing of initiation, completion, and results and data of Legend Biotech’s early-stage cell therapy portfolio; statements relating to CARVYKTI®, including Legend Biotech’s expectations for CARVYKTI® and its therapeutic potential; statements related to Legend Biotech’s ability to fund its operations beyond 2026 and to achieve profitability in 2026; and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the Securities and Exchange Commission (SEC) on March 10, 2026 and Legend Biotech’s other filings with the SEC. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
(UNAUDITED, DOLLARS IN MILLIONS, EXCEPT PER SHARE DATA)
Three Months Ended
March 31, 2026 2025REVENUE License and other revenue*$6.7 $9.4 Collaboration revenue 298.4 185.6 Total revenue 305.1 195.0 Cost of collaboration revenue (175.4) (69.5)Cost of license and other revenue (0.5) (1.8)Research and development expenses (85.7) (101.9)Administrative expenses (40.0) (31.5)Selling and distribution expenses (50.1) (41.0)Other operating expenses** (3.2) (1.0)Operating loss (49.8) (51.7)Finance costs (5.5) (5.1)Finance income 7.3 12.1 Other expense, net (5.1) (54.5)Loss before tax (53.1) (99.2)Income tax expense (1.2) (1.8)Net loss$(54.3) $(101.0) LOSS PER SHARE Basic$(0.15) $(0.27)Diluted$(0.15) $(0.27) Weighted average shares outstanding: Basic 370.2 367.5 Diluted 370.2 367.5 *Certain prior year amounts included within other revenue have been combined into the license and other revenue line for comparative purposes.
** Certain prior year amounts have been reclassified to present loss on asset impairment into the other operating expenses line for comparative purposes.
LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(DOLLARS IN MILLIONS)
March 31, 2026
December 31, 2025
(Unaudited) NON-CURRENT ASSETS Property, plant and equipment$121.4 $116.3 Right-of-use assets 331.1 285.2 Collaboration prepaid leases 35.0 72.7 Other non-current assets 26.5 12.4 Total non-current assets 514.0 486.6 CURRENT ASSETS Collaboration inventories, net 37.1 32.0 Trade receivables 1.7 13.1 Prepayments, other receivables and other assets 209.3 253.4 Time deposits 188.2 46.7 Cash and cash equivalents 646.4 901.9 Total current assets 1,082.7 1,247.1 TOTAL ASSETS$1,596.7 $1,733.7 CURRENT LIABILITIES Trade payables$74.3 $83.0 Tax payable 20.3 19.2 Other payables and accruals 130.2 195.4 Lease liabilities 11.2 7.4 Contract liabilities 6.0 11.3 Collaboration interest-bearing advanced funding 266.0 319.1 Other current liabilities 1.1 1.0 Total current liabilities 509.1 636.4 NON-CURRENT LIABILITIES Lease liabilities long term 112.1 87.2 Other non-current liabilities 7.8 8.0 Total non-current liabilities 119.9 95.2 TOTAL LIABILITIES$629.0 $731.6 EQUITY Share capital 0.1 0.1 Reserves 967.6 1,002.0 Total equity$967.7 $1,002.1 TOTAL LIABILITIES AND SHAREHOLDER'S EQUITY$1,596.7 $1,733.7 LEGEND BIOTECH CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(UNAUDITED; DOLLARS IN MILLIONS)
Three Months Ended March 31, 2026 2025Loss before tax$(53.1) $(99.2)Cash flows used in operating activities (85.1) (103.6)Cash flows (used in) provided by investing activities (168.0) 256.6 Cash flows (used in) provided by financing activities (1.2) 0.6 Effect of foreign exchange rate changes, net (1.2) 1.4 Net (decrease) increase in cash and cash equivalents (255.5) 155.0 Cash and cash equivalents at beginning of the period 901.9 286.7 CASH AND CASH EQUIVALENTS AT END OF THE PERIOD$646.4 $441.7 ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS Cash and bank balances$834.6 $1,005.5 Less: Pledged deposits — 0.1 Time deposits 188.2 563.7 Cash and cash equivalents as stated in the statement of financial position$646.4 $441.7 RECONCILIATION OF IFRS TO NON-IFRS MEASURES
We use Adjusted Net Loss and Adjusted Net Loss per Share (which we sometimes refer to as “Adjusted EPS” “ANL per Share”) as performance metrics. Adjusted Net Loss and ANL per share are not defined under IFRS, are not a measure of operating income, operating performance, or liquidity presented in accordance with IFRS, and are subject to important limitations. Our use of Adjusted Net Loss has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. For example:
Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted Net Loss does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements.Adjusted Net Loss excludes unrealized foreign exchange gain or loss.Adjusted Net Loss does not reflect changes in, or cash requirements for, our working capital needs.In addition, Adjusted Net Loss excludes such as share based compensation expense, which has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy. Also, our definition of Adjusted Net Loss and ANL per Share may not be the same as similarly titled measures used by other companies.
However, we believe that providing information concerning Adjusted Net Loss and ANL per Share enhances an investor’s understanding of our financial performance. We use Adjusted Net Loss as a performance metric that guides management in its operation of and planning for the future of the business. We believe that Adjusted Net Loss provides a useful measure of our operating performance from period to period by excluding certain items that we believe are not representative of our core business. We define Adjusted Net Loss as net loss adjusted for (1) non-cash items such as depreciation and amortization, share based compensation, impairment loss, and (2) unrealized foreign exchange gain or loss.
ANL per Share is computed by dividing Adjusted Net Loss by the weighted average shares outstanding.
A reconciliation between Adjusted Net Loss and Net Loss, the most directly comparable measure under IFRS, has been provided in the table below.
LEGEND BIOTECH CORPORATION
RECONCILIATION OF IFRS TO NON-IFRS
(UNAUDITED; DOLLARS IN MILLIONS, EXCEPT PER SHARE DATA) Three Months ended March 31, 2026 2025Net loss$(54.3) $(101.0)Depreciation and amortization 15.7 5.3 Share-based compensation 19.3 15.9 Impairment charges (1) 2.9 1.0 Unrealized foreign exchange loss/(gain) (2) 5.9 51.8 Adjusted net loss (ANL)$(10.5) $(27.0) ANL per share: ANL per share - basic$(0.03) $(0.07)ANL per share - diluted$(0.03) $(0.07) (1) Included in Other operating expenses
(2) Included in Other income/(expense), net
Roots (TSE:ROOT) reported higher first-quarter sales for fiscal 2026 as growth in its direct-to-consumer business and partner channels helped offset pressure from temporary gross margin headwinds and higher project-related expenses. President and Chief Executive Officer Meghan Roach said the compan
TSE:ROOT
Read Roots Q1 Earnings Call Highlights
2 hours ago
Motorpoint Group H2 Earnings Call HighlightsMarketBeat
Motorpoint Group (LON:MOTR) reported record retail volumes and a sharp increase in profit for its 2026 financial year, with management saying data-led pricing, improved vehicle supply and operational efficiency helped the used-car retailer expand margins while growing sales. Chief Executive Officer
Legend Biotech Corp (NASDAQ:LEGN) reported downbeat results for the first quarter on Tuesday.
The company posted quarterly losses of 3 cents per share which missed the analyst consensus estimate of losses of 2 cents per share. The company reported quarterly sales of $305.100 million which missed the analyst consensus estimate of $307.035 million.
Legend Biotech shares rose 1.3% to trade at $28.63 on Wednesday.
These analysts made changes to their price targets on Legend Biotech following earnings announcement.
RBC Capital analyst Leonid Timashev maintained Legend Biotech with an Outperform rating and raised the price target from $62 to $64. Morgan Stanley analyst Matthew Harrison maintained the stock with an Overweight rating and lowered the price target from $49 to $48. TD Cowen analyst Yaron Werber maintained the stock with a Hold and raised the price target from $21 to $29. Considering buying LEGN stock? Here’s what analysts think:
Photo via Shutterstock
Market News and Data brought to you by Benzinga APIs
This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.
Biotech dealmaking accelerated heading into the JPM 2026 Healthcare Conference as large drugmakers face looming patent cliffs and hunt for growth. Five therapeutic categories are absorbing most strategic capital: radiopharmaceuticals, next-gen GLP-1, autologous CAR-T, allogeneic cell therapy, and antibody-drug conjugates. Below are the publicly traded category leaders in each. Each is a well-positioned standalone business with M&A optionality, not a takeout prediction.
5. ADC Therapeutics: Pure-Play ADCs ADC Therapeutics (NYSE: ADCT) is one of the few remaining pure-play, commercial-stage ADC names after Pfizer paid $43 billion for Seagen and AbbVie bought ImmunoGen. Lead drug Zynlonta generated $20.03 million in Q1 2026 net product revenue, up 15% year over year, and Q1 revenue of $20.85 million beat the consensus estimate.
The major catalyst is LOTIS-5 Phase 3 topline data expected in Q2 2026, with peak U.S. revenue potential pegged at $600 million to $1 billion and cash runway into 2028. Risks include negative shareholders’ equity of $216.4 million, a Portnoy Law Firm investigation announced in April 2026 over LOTIS-7 safety, and Redmile Group disposing roughly 5.9 million shares in early April 2026. Shares trade near $3.50 apiece.
4. Allogene Therapeutics: Off-the-Shelf CAR-T Allogene Therapeutics (NASDAQ: ALLO) leads the allogeneic CAR-T category that big pharma views as the manufacturing solution to the scalability challenges of patient-specific autologous therapy. The ALPHA3 interim analysis showed 58.3% measurable residual disease (MRD) clearance, versus 16.7% in the observation arm, with no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease. Q1 EPS met expectations at −$0.18, and an April 2026 raise of $200.4 million (gross) extended the runway into Q1 2029.
The challenge is scale. The market cap is roughly $803.9 million, the stock trades near $2.30, and shares are down 23.9% over the past month after the dilutive offering. Long-dated catalysts (interim EFS mid-2027) keep this in the higher-risk bucket.
3. Legend Biotech: The Autologous Powerhouse Legend Biotech (NASDAQ: LEGN | LEGN Price Prediction) anchors the autologous CAR-T category through its heavyweight partnership with Johnson & Johnson. In recent clinical updates, Carvykti demonstrated a 99% overall response rate (ORR) and 86% complete response/stringent complete response in the CARTITUDE-4 study, with a 94% MRD negativity rate that underscores its “best-in-class” efficacy.
Financial momentum is equally robust: Carvykti generated $597 million in Q1 2026 net trade sales, a 62% year-over-year increase. With a cash position of approximately $1.3 billion and a runway extending through 2026 profitability, Legend has largely de-risked its balance sheet. However, some risks persist, including high operational expenses related to the massive Obelisc manufacturing expansion. Shares are trading for more than $28.00 after a 62.1% rally in the past month, driven by those blowout sales figures and renewed acquisition speculation.
2. Viking Therapeutics: Next-Gen GLP-1 Viking Therapeutics (NASDAQ: VKTX) is the most-named independent in obesity. VK2735 is a dual GLP-1/GIP agonist with VANQUISH-1 fully enrolled (about 4,500 patients) ahead of schedule, and oral VK2735 produced up to 12.2% mean weight reduction at 13 weeks in Phase 2. Phase 2 VENTURE data appeared in the journal Obesity in January 2026.
Polymarket currently prices a 59.5% implied probability of Viking being acquired before 2027, though that figure reflects thin-volume prediction-market sentiment and should be interpreted cautiously. The consensus analyst target stands at $92.33, well above the current share price of approximately $31.50. Risks include a FY2025 net loss of $359.64 million and a Q4 EPS miss of −$1.38 versus the −$0.8958 consensus.
1. Lantheus: Radiopharmaceuticals Lantheus Holdings (NASDAQ: LNTH) tops the list as the only profitable, commercial-scale name beating expectations every quarter. Q1 2026 revenue of $377.33 million exceeded the $354.42 million consensus by 6.46%, and adjusted EPS of $1.46 beat the $1.2292 estimate by 18.78%. Definity grew 6.8%, and Neuraceq added $35.44 million, partially offsetting Pylarify’s 6.5% year-over-year decline.
Management reaffirmed FY2026 revenue guidance of $1.40 billion to $1.45 billion and adjusted EPS of $5.00 to $5.25, and the company secured FDA approval for Pylarify TruVu ahead of a planned Q4 2026 phased launch. CEO Mary Anne Heino said the team is “laying the groundwork for growth acceleration beginning in 2027.” Shares are up 44.9% year to date to around $96.50 and trade at a 23x trailing P/E. The SPECT business sale closed in January 2026, sharpening focus on radiopharma—a space where Novartis has built a franchise around Pluvicto.
A Framework for Retail Investors Buying biotech purely on takeout hopes is a coin flip. The cleaner approach is owning category leaders whose standalone fundamentals justify the position, with M&A optionality as a free call. Lantheus offers the strongest standalone profile; Viking, Legend, Allogene, and ADC Therapeutics carry higher clinical and dilution risk for bigger asymmetric payoffs. Position sizing matters most, because biotech drawdowns can be severe and unforgiving.
First Beijing Investment Ltd disclosed a new position in Legend Biotech (LEGN +4.07%), acquiring 2,296,335 shares in the first quarter, with the estimated trade valued at $43.78 million based on average quarterly pricing, according to a May 13, 2026, SEC filing.
Legend Biotech develops cell therapies for cancer, with a pipeline spanning hematologic malignancies and solid tumors.
Initiated new stake: 2,296,335 shares; estimated trade value $43.78 million (based on quarterly average price)Quarter-end position value at $41.54 million, representing a net valuation change that includes price movementsTrade represented a 1.89% increase in 13F reportable assets under managementPost-trade: 2,296,335 shares held, valued at $41.54 millionPosition accounts for 1.79% of 13F AUM, which places it outside the fund's top five holdingsWhat happenedAccording to an SEC filing dated May 13, 2026, First Beijing Investment Ltd established a new stake in Legend Biotech, purchasing 2,296,335 shares. The estimated transaction value was $43.78 million, calculated using the average closing price for the first quarter. The quarter-end value of this position stood at $41.54 million, reflecting both purchase activity and share price movement during the period.
What else to knowNew position: stake represents 1.79% of 13F reportable assets under management as of March 31, 2026Top holdings after the filing:NASDAQ: PDD: $832.68 million (35.9% of AUM)NYSE: YMM: $747.01 million (32.2% of AUM)NYSE: EDU: $509.40 million (22.0% of AUM)NYSE: RLX: $132.29 million (5.7% of AUM)NASDAQ: KSPI: $32.17 million (1.4% of AUM)As of May 15, 2026, Legend Biotech shares were priced at $27.55, down 0.5% over the prior year, underperforming the S&P 500 by 25.7 percentage pointsCompany OverviewMetricValuePrice (as of market close 2026-05-15)$27.55Market Capitalization$5.08 billionRevenue (TTM)$1.14 billionNet Income (TTM)($250.98 million)Company SnapshotLegend Biotech develops and commercializes novel cell therapies, including its lead CAR-T product candidate for multiple myeloma and a pipeline targeting various hematologic malignancies and solid tumors.The company generates revenue primarily through the development and licensing of its cell therapy portfolio, leveraging strategic collaborations such as its agreement with Janssen Biotech for ciltacabtagene autoleucel.Legend Biotech targets oncology patients, healthcare providers, and pharmaceutical partners in the United States, China, and international markets.Legend Biotech Corporation is a clinical-stage biopharmaceutical company focused on advancing innovative cell therapies for cancer and related diseases. The company leverages proprietary CAR-T technologies and strategic partnerships to address high unmet medical needs in oncology. With a growing portfolio and international presence, Legend Biotech aims to establish a competitive position in the global biotechnology sector.
What this transaction means for investorsFirst Beijing runs a hyper-concentrated book — three names make up roughly 90% of its reported assets, all in Chinese tech and consumer. Adding Legend Biotech at 1.79% of AUM is a toe-dip into a different corner of the China ADR universe, not a conviction call. The stock had already given back meaningful ground before this position was opened, which is worth knowing, but the filing doesn't tell you why First Beijing bought or what their target is. A small new position from a fund this concentrated says less than the same allocation would from a more diversified manager. If you're trying to decide whether Legend Biotech belongs in your portfolio, the CAR-T pipeline and the Janssen partnership are the questions that matter — this 13F just tells you one institution got off the sidelines at a depressed price.
Seena Hassouna has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Joint Stock Kaspi.kz and Legend Biotech. The Motley Fool has a disclosure policy.
Preliminary results from Phase 1 data for LB2102 to reinforce early evidence of activity in solid tumors in a rapid oral presentation New data from the CARTITUDE-4 study to highlight a cytogenetic subgroup analysis of patients who responded to bridging therapy will be featured in a poster presentationCompany to host on-site investor relations event and webcast on Sunday, May 31, at 6:15 p.m. CT
SOMERSET, N.J., May 21, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, today announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, including a rapid oral presentation highlighting preliminary Phase 1 data for LB2102, its investigational DLL3-targeted CAR-T therapy for relapsed or refractory small-cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma (LCNEC).
The Company will also present new data on CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) at ASCO, contributing to the growing body of clinical evidence from the CARTITUDE program that supports its demonstrated efficacy and safety profile in patients with multiple myeloma.
“ASCO provides an important forum to share advancements across our emerging and established CAR-T cell therapy programs,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “The rapid oral presentation for LB2102 underscores continued progress in extending CAR-T approaches into solid tumors, with preliminary data demonstrating a manageable safety profile and early evidence of clinical activity. Additionally, new analyses of CARVYKTI further reinforce the robust clinical profile demonstrated across several studies in multiple myeloma.”
LB2102 represents part of the Company’s broader strategy to expand CAR-T therapies beyond hematologic malignancies and into solid tumors. In November 2023, Legend Biotech’s subsidiary, Legend Biotech Ireland Limited, entered into a license agreement with Novartis Pharma AG (the Novartis Agreement), granting Novartis an exclusive worldwide license to develop, manufacture, and commercialize certain Legend Biotech CAR-T cell therapies targeting DLL3.
Under the Novartis Agreement, Legend Biotech is responsible for conducting the current Phase 1 clinical trial of LB2102 in the United States, while Novartis is responsible for conducting all other development, manufacturing, and commercialization for the licensed products, including LB2102.
In addition to the LB2102 presentation, a subgroup analysis of patients from the CARTITUDE-4 trial who responded to bridging therapy will be presented as a poster. The data highlights the efficacy and safety of patients who received treatment according to their risk level—both high and standard-risk cytogenetics—and achieved a partial response or better after bridging therapy.
Additionally, a separate multi‑study analysis on the incidence and characterization of immune effector cell-associated enterocolitis (IEC-EC) from CARVYKTI® clinical trials will also be presented as a poster.
CARVYKTI® is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI® is now commercially available in 18 countries and has been used to treat more than 10,000 patients to date.
ASCO Presentations (May 29-June 2, 2026)
Abstract No.TitleInformationAbstract #8012
Rapid Oral PresentationPreliminary results from an ongoing Phase 1 study of LB2102, a dnTGFBR2-armored DLL3-targeted autologous CAR-T cell therapy, in patients with relapsed or refractory SCLC or LCNECSession Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date/Time: Sunday, May 31, 2026, 5:00–5:06 PM CDT
Location: Arie Crown TheaterAbstract #7533
PosterImmune effector cell-associated enterocolitis (IEC-EC) incidence and characterization in cilta-cel-treated patients with RRMM in CARTITUDE clinical studiesSession Title: Hematologic Malignancies—Plasma Cell Dyscrasia
Poster Board: 412
Date/Time: Monday, June 1, 2026, 9:00 AM-12:00 PM CDT
Location: Hall A
Abstract #7536
PosterCiltacabtagene autoleucel in lenalidomide-refractory multiple myeloma responding to bridging therapy: CARTITUDE-4 cytogenetic subgroup analysisSession Title: Hematologic Malignancies—Plasma Cell Dyscrasia
Poster Board: 415
Date/Time: Monday, June 1, 2026, 9:00 AM-12:00 PM CDT
Location: Hall A
Investor Relations Event Details:
Legend Biotech will host an in-person investor relations event on Sunday, May 31, 2026, at 6:15 p.m. CT (7:15 p.m. ET) during the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
The event will feature clinician experts and a discussion about how CARVYKTI® is transforming the multiple myeloma treatment landscape.
Investors and other interested parties may join the live webcast through this weblink or by visiting Legend Biotech’s website under Events and Presentations.
CARVYKTI® IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIESCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed.
Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®.
Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®.
Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI®. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®.
WARNINGS AND PRECAUTIONS
INCREASED EARLY MORTALITY – In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).
CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI®.
Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.
Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.
Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (≥2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%).
Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.
Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.
Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment.
Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.
Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.
Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.
Peripheral Neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff.
Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.
Cranial Nerve Palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).
The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.
Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.
Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®.
HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.
PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.
Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.
INFECTIONS: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI® infusion.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.
Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.
Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.
HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis.
Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®.
HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.
Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.
IMMUNE EFFECTOR CELL-ASSOCIATED ENTERCOLITIS (IEC-EC) has occurred in patients treated with CARVYKTI®. Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.
In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.
SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.
Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.
ADVERSE REACTIONS
The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.
Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®.
ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)
Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.i
In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.
In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.
ABOUT MULTIPLE MYELOMA
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.ii In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.iii While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems, or infections.iv
ABOUT CARTITUDE-4
CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.v
ABOUT LB2102
NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.vi
ABOUT SMALL-CELL LUNG CANCER
Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.vii Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.viii,ix An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year.16 This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.15,x
ABOUT LEGEND BIOTECH
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X and LinkedIn.
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to: Legend Biotech’s strategies and objectives; the benefits of CARVYKTI, including its emerging curative potential; and the potential of LB2102, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
_________________________
i CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
ii American Cancer Society. “What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html.Accessed March 2024.
iii American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html.Accessed March 2024.
iv American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023.
v ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024.
vi ClinicalTrials.gov. DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: https://www.clinicaltrials.gov/study/NCT05680922. Accessed May 2025
vii American Cancer Society. “Key Statistics for Lung Cancer.” https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed November 2022.
viii Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.
ix Rare Diseases. “Rare Disease Database.” https://rarediseases.org/rare-diseases/small-cell-lung-cancer. Accessed November 2022.
x Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6):359-66.
CPI Data Sparks Rally in Biotech StocksLegend Biotech NASDAQ: LEGN used an investor and analyst event to highlight long-term data and physician perspectives supporting broader use of CARVYKTI, its BCMA-directed CAR T-cell therapy for multiple myeloma developed, manufactured and co-promoted with Johnson & Johnson.
Chief Executive Officer Ying Huang said Legend is the “world’s largest standalone cell therapy company” and described CARVYKTI as the “fastest commercial launch among all CAR T therapies to date.” Huang said the product generated nearly $2 billion in total sales in 2025 and has treated more than 10,000 patients to date. She also said Legend had $835 million in cash and liquidity at the end of the first quarter and expects to achieve corporate profitability this year on an adjusted net income basis.
Get Legend Biotech alerts:
Why Legend Biotech Stock Is Having Its Best Month YetThe event focused on CARVYKTI’s long-term efficacy, the case for earlier use in multiple myeloma and evolving safety management practices. Huang said the company views CARVYKTI as a one-time infusion that can be used in inpatient or outpatient settings and may offer lifetime cost savings for patients, healthcare practitioners and payers.
Physicians Highlight Long-Term Data and “Curative Potential” Dr. Binod Dhakal, associate professor of medicine at the Medical College of Wisconsin, said CARVYKTI has changed how physicians discuss multiple myeloma, historically considered an incurable cancer.
Dhakal pointed to a proposed International Myeloma Working Group definition of cure in multiple myeloma, which includes sustained treatment-free minimal residual disease, or MRD, negativity for five years, sustained complete response, repeated MRD assessments and no evidence of disease by imaging.
Discussing long-term CARTITUDE-1 follow-up, Dhakal said that among 97 treated patients, about one-third were treatment-free and progression-free for more than five years after a single infusion. He also said 12 patients at one center with annual MRD and PET assessments were MRD negative and PET negative for five years, meeting the proposed definition of cure.
Dhakal said median overall survival in CARTITUDE-1 was about 61 months in a heavily pretreated population with a median of six prior lines of therapy. He contrasted that with historical expectations for similar triple-class exposed patients, saying they would have had median overall survival of less than a year.
Doctors Say Earlier CAR T Use May Improve Outcomes Dr. Doris Hansen, assistant member of blood and marrow transplant and cellular immunotherapy at Moffitt Cancer Center, argued that earlier treatment with CARVYKTI is preferable because multiple myeloma becomes more difficult to treat and more genomically complex with each line of therapy.
Hansen said patients are lost at each treatment line, with attrition rates between 10% and 30% per line of therapy. She cited CARTITUDE-1 and CARTITUDE-4 data, including median progression-free survival of about three years in heavily pretreated CARTITUDE-1 patients and median progression-free survival as high as 50 months in certain triple-class exposed patients with three prior lines of therapy. In CARTITUDE-4, she said median progression-free survival had not been reached at 30 months in patients who were proteasome inhibitor and IMiD exposed and lenalidomide refractory.
Hansen also said safety appears to improve when CARVYKTI is used earlier. She noted that Parkinsonism was reported in 6% of patients in CARTITUDE-1 at five years, while CARTITUDE-4 had one patient with Parkinsonian features, or less than 1%. She added that manufacturing success was 99% when CAR T was moved earlier in the disease course.
In the question-and-answer session, Hansen said she is treating all eligible patients in second line with CARVYKTI, whether they are functional high risk or standard risk, unless logistical or comorbidity issues prevent it. Dhakal and Dr. Surbhi Sidana, associate professor of medicine at Stanford University, described similar practice patterns, saying they recommend CAR T as early as first relapse for eligible patients.
Bridging Therapy Emphasized as Safety Strategy Sidana focused on safety management and said disease burden before CARVYKTI treatment is an important factor. She said patients who did not respond well to bridging therapy had worse progression-free survival and overall survival, and that going into CARVYKTI with high disease burden is “not a good idea.”
Sidana cited multiple data sets, including CARTITUDE-4 and real-world consortium data, to argue that CARVYKTI should be used as a consolidative therapy after effective disease debulking. In a U.S. Multiple Myeloma CAR T Consortium data set of more than 750 patients, she said 21 of 22 Parkinsonism cases occurred in patients who had not responded to bridging therapy. She said the risk of Parkinsonism was 5% in non-responders compared with 0.5% in patients with a partial response or better to bridging therapy.
Sidana said manufacturing constraints are “a non-issue” at this point and that bridging options depend on the patient’s prior treatments and refractory status. She said talquetamab is often used in more refractory patients, while earlier-line patients may receive other options such as daratumumab-based bridging if appropriate.
CAR T Versus Bispecifics and Future Treatment Settings The panel also discussed sequencing CARVYKTI with bispecific antibodies. Dhakal said that for eligible patients, his preference is to offer CAR T first, citing CARVYKTI’s potential curative option, one-time treatment and quality-of-life considerations. Hansen said Immunotherapy Working Group guidance recommends CAR before bispecific therapy for eligible patients.
A company representative also discussed two real-world data sets, including a German registry of 606 patients and a U.S. TriNetX analysis of 389 patients. The representative said both supported the idea that earlier CARVYKTI use and CAR T before bispecific therapy were associated with better outcomes, while cautioning that the TriNetX analysis was not randomized and could not perfectly match patient characteristics.
Panelists said they are awaiting data from ongoing frontline studies, including CARTITUDE-5 in transplant-ineligible or transplant-delayed patients and CARTITUDE-6 comparing CARVYKTI head-to-head against transplant in transplant-eligible patients. Sidana said the field is moving toward using the most effective therapies earlier, but added that physicians need to wait for the data.
Asked about in vivo CAR T approaches, Hansen, Sidana and Dhakal described the technology as exciting but early. Hansen said there is limited follow-up and more information is needed on safety and durability. Huang declined to provide details on Legend’s own in vivo program ahead of a medical meeting abstract publication.
Legend also said demand is shifting earlier. A company representative said that, on the most recent earnings call, the company reported 41% of CARVYKTI patients were coming from second and third line treatment settings. The representative said Legend is expanding education, treatment-center access and patient activation efforts, including targeted direct-to-consumer advertising and outreach through social media.
About Legend Biotech NASDAQ: LEGNLegend Biotech NASDAQ: LEGN is a commercial-stage biopharmaceutical company specializing in the development and commercialization of chimeric antigen receptor T-cell (CAR-T) therapies for oncology. Headquartered in Somerset, New Jersey, with research and development operations in Shanghai, the company leverages a global infrastructure to advance innovative cellular therapies. Legend Biotech pursues a strategy of strategic collaboration to extend its reach, most notably through its partnership with Janssen Biotech, a subsidiary of Johnson & Johnson.
The company's lead asset, ciltacabtagene autoleucel (commercially marketed as Carvykti), is a B-cell maturation antigen (BCMA)–directed CAR-T therapy for the treatment of relapsed or refractory multiple myeloma.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
Should You Invest $1,000 in Legend Biotech Right Now?Before you consider Legend Biotech, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Legend Biotech wasn't on the list.
While Legend Biotech currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.
View The Five Stocks Here
Discover the 10 Best High-Yield Dividend Stocks for 2026 and secure reliable income in uncertain markets. Download the report now to identify top dividend payers and avoid common yield traps.
LB2102 demonstrated a manageable safety profile and encouraging clinical activity in solid tumors among heavily pretreated patients Responses observed at higher dose levels of LB2102 with an ORR of 28.6% and a DCR of 78.6%, with durable responses seen in some patients New CARVYKTI® data continue to support durable efficacy and a consistent safety profile in multiple myeloma
BRIDGEWATER, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, today announced first-in-human clinical data for LB2102, its investigational DLL3-targeted CAR-T cell therapy for patients with relapsed or refractory small cell lung cancer (SCLC) or large-cell neuroendocrine carcinoma (LCNEC). The data demonstrate early evidence of clinical activity and a manageable safety profile. At higher dose levels, an objective response rate (ORR) of 28.6% and disease control rate (DCR) of 78.6% were observed, including durable responses in some heavily pretreated patients.
The data, presented in a rapid oral presentation (Abstract #8012) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, support the clinical potential of CAR-T cell therapy in solid tumors.
Additionally, new analyses from the CARTITUDE program were presented, further highlighting sustained clinical benefit and a consistent safety profile for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in multiple myeloma.
“The data presented at ASCO underscores the progress of our next-generation pipeline and the meaningful impact that CARVYKTI continues to deliver to patients,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “LB2102 marks an early step in expanding CAR-T cell therapy into solid tumors, addressing the unique challenges where current treatment options are limited and early data show promising clinical activity in difficult-to-treat cancers. At the same time, CARVYKTI continues to demonstrate durable efficacy and a consistent safety profile, reinforcing its role as a transformative therapy for multiple myeloma and supporting our leadership in cell therapy.”
LB2102: Early Evidence of Clinical Activity Observed in Solid Tumors
Early Phase 1 results from the ongoing study of LB2102 demonstrate encouraging anti-tumor activity and a manageable safety profile in patients with relapsed or refractory (R/R) SCLC or LCNEC, a population characterized by advanced disease and limited treatment options.
LB2102 is an investigational DLL3-targeted autologous CAR-T cell therapy with dnTGFBR2 Armor engineered to enhance activity by overcoming immunosuppressive signaling within the tumor microenvironment.
Efficacy Results
Objective response rate (ORR): 20% (4/20)Disease control rate (DCR): 70% (14/20)At dose level ≥3: ORR: 28.6%DCR: 78.6%Median duration of disease control: 6.1 months Median duration of response: 6.5 monthsOngoing responses were observed in 2 patients at data cutoff Safety Results
No dose-limiting toxicities or treatment-related deathsCytokine release syndrome (CRS) occurred in 30% of patients (all Grade ≤2)Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 15% of patients (two Grade 1 and one Grade 3)Most Grade ≥3 adverse events were hematologic and co-attributed to lymphodepletion “Patients with relapsed or refractory SCLC or LCNEC have historically had very limited treatment options and poor outcomes,” said Zhonglin Hao, M.D., Ph.D., Professor of Medicine and Cancer Biology, Director, Thoracic Oncology Program, University of Kentucky Markey Cancer Center. “Durable disease control and responses at higher dose levels with LB2102 are encouraging, particularly alongside a manageable safety profile. These findings support continued evaluation of CAR-T approaches in solid tumors, where effective therapies remain limited.”‡
LB2102 represents part of the Company’s broader strategy to expand CAR-T therapies beyond hematologic malignancies and into solid tumors. In November 2023, Legend Biotech’s subsidiary, Legend Biotech Ireland Limited, entered into a license agreement with Novartis Pharma AG (the Novartis Agreement), granting Novartis an exclusive worldwide license to develop, manufacture, and commercialize certain Legend Biotech CAR-T cell therapies targeting DLL3.
Under the Novartis Agreement, Legend Biotech is responsible for conducting the current Phase 1 clinical trial of LB2102 in the United States, while Novartis is responsible for conducting all other development, manufacturing, and commercialization for the licensed products, including LB2102.
CARVYKTI®: Ongoing Clinical Data in Multiple Myeloma
New analyses from the CARTITUDE program continue to demonstrate sustained clinical benefit and consistent safety profile of CARVYKTI® in patients with multiple myeloma.
In the CARTITUDE-4 subgroup analysis (Abstract #7536), progression-free survival and overall survival benefits were observed across both high-risk and standard-risk cytogenetic populations among patients who responded to bridging therapy, with 30-month OS rates greaterthan 85%.No cases of immune effector cell (IEC)–associated Parkinsonism were reported.
In a separate multi-study analysis (Abstract #7533), a low incidence (1.2%) of IEC-associated enterocolitis (IEC-EC) was observed, further characterizing this uncommon adverse event and reinforcing the overall favorable benefit-risk profile of CARVYKTI®.
CARVYKTI® is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI® is now commercially available in 18 countries and has been used to treat more than 10,000 patients to date.
CARVYKTI® IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIESCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed.
Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®.
Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®.
Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI®. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®.
WARNINGS AND PRECAUTIONS
INCREASED EARLY MORTALITY - In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).
CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI®.
Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.
Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.
Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (≥2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%).
Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.
Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.
Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).
Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment.
Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.
Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.
Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.
Peripheral Neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff.
Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.
Cranial Nerve Palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).
The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.
Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.
Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®.
HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.
PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.
Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.
INFECTIONS: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI® infusion.
Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.
Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.
Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.
HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis.
Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®.
HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.
Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.
IMMUNE EFFECTOR CELL-ASSOCIATED ENTERCOLITIS (IEC-EC) has occurred in patients treated with CARVYKTI®. Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.
In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.
SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.
Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.
ADVERSE REACTIONS
The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.
Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®.
ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)
Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.i
In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.
In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.
ABOUT MULTIPLE MYELOMA
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.ii In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.iii While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems, or infections.iv
ABOUT CARTITUDE-4
CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.v
ABOUT LB2102
NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.vi
ABOUT SMALL-CELL LUNG CANCER
Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.vii Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.viii,ix An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year. This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.,x
ABOUT LEGEND BIOTECH
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X, Instagram, and LinkedIn.
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to: Legend Biotech’s strategies and objectives; the benefits of CARVYKTI, including its emerging curative potential; and the potential of LB2102, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
‡ Zhonglin Hao, M.D., Ph.D., Professor of Medicine and Cancer Biology, Director, Thoracic Oncology Program, University of Kentucky Markey Cancer Center, has provided consulting and advisory services to Legend Biotech; he has not been paid for any media work.
i CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
ii American Cancer Society. “What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html.Accessed March 2024.
iii American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html.Accessed March 2024.
iv American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023.
v ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024.
vi ClinicalTrials.gov. DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: https://www.clinicaltrials.gov/study/NCT05680922. Accessed May 2025
vii American Cancer Society. “Key Statistics for Lung Cancer.” https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed November 2022.
viii Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.
ix Rare Diseases. “Rare Disease Database.” https://rarediseases.org/rare-diseases/small-cell-lung-cancer. Accessed November 2022.
x Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6):359-66.
June 02, 2026 09:30 ET | Source: Legend Biotech USA Inc.
Promising Phase 1 data for LB2501, a potential first‑in‑class CD19/CD20 dual‑targeting in vivo CAR-T therapy, as an off-the-shelf, single-infusion treatment for B‑cell malignanciesAn ORR of 100% (6/6) was observed in the dose level 2 cohort, including CR rate of 83.3% (5/6) in patients with relapsed/ refractory NHLData demonstrate robust in vivo CAR-T expansion without lymphodepleting chemotherapy Favorable safety profile: no DLTs, no SAEs, no ICANS, CRS <Grade 2 BRIDGEWATER, N.J., June 02, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, today announced that promising preliminary clinical data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL), will be presented during a late-breaking session at the European Hematology Association (EHA) 2026 Congress, taking place June 11-14, 2026, in Stockholm, Sweden.
“The upcoming presentation of Phase 1 LB2501 data in patients with B-cell malignancies represents an important step in advancing in vivo CAR-T approaches,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “By generating CAR-T cells directly within the patient, this approach has the potential to simplify treatment delivery and expand access for patients who may not be able to receive traditional CAR-T cell therapies. LB2501 is built on the TaVec™ platform, which is a proprietary lentiviral vector engineered to enhance T-cell specificity, transduction efficiency, and safety, while restricting transduction of non-T cells.”
LB2501: Promising Phase 1 Trial of In Vivo CAR-T Data Demonstrate High Response Rates in B-cell Malignancies
Data from 12 patients across two dose cohorts in an ongoing Phase 1 study evaluating LB2501 in patients with R/R B-NHL provide early clinical evidence supporting the potential of an in vivo CAR-T approach in B-cell malignancies. LB2501 is designed to generate CAR-T cells directly within the patient following a single intravenous infusion, eliminating the need for cell manufacturing and lymphodepletion.
As of April 1, 2026, 12 patients with R/R B-NHL were treated across two dose levels (DL1 and DL2). Additional details will be presented at EHA 2026. Key findings from the abstract include:
Efficacy Results
At DL2 (median follow-up for DL2 was 2.2 months [range, 2.0 to 3.8]) Objective response rate (ORR): 100% (6/6)Complete response rate (CR): 83.3% (5/6)All responses were ongoing at data cutoff Pharmacokinetics
Dose-dependent in vivo CAR-T expansion observedCAR-T cells detected in peripheral blood for up to 116 days Safety Results
No dose-limiting toxicities (DLTs), serious adverse events (SAEs), or deaths were observedInfusion-related reactions occurred in 75% of patients, all of which were ≤ Grade 2Cytokine release syndrome (CRS) occurred in 66.7% of patients, all of which were ≤ Grade 2No immune effector cell-associated neurotoxicity syndrome (ICANS) was reportedGrade ≥3 lentiviral vector-related and CAR-T-related adverse events were limited to decreased lymphocyte count and decreased neutrophil count EHA Presentation (June 11-14, 2026)
Abstract No.TitleInformationAbstract #LB5006
Late-Breaking Oral PresentationFirst-in-human trial of LB2501, an in vivo CD19/CD20 dual targeting CAR-T therapy, in relapsed/refractory B-Cell NHLSession ID: s204
Date/Time: Sunday, June 14, 2026, 9:15-10:45 AM CEST
Location: Nobel Hall ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study NCT07002112) in patients with relapsed/refractory B-cell malignancies to assess safety, tolerability, and preliminary efficacy.i
ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.iii
ABOUT LEGEND BIOTECH
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X, Instagram, and LinkedIn.
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives, the potential benefits of the proprietary TaVec platform, the Phase 1 clinical trial of LB2501 and the potential benefits of LB2501, including its potential to be first-in-class. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by Legend Biotech’s third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
i ClinicalTrials.Gov. The CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies. https://clinicaltrials.gov/study/NCT07002112. Accessed May 2026
ii American Cancer Society. “What Is Non-Hodgkin Lymphoma?”. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html.Accessed May 2026.
iii American Cancer Society. “Types of B-cell Lymphoma.” Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/b-cell-lymphoma.html.Accessed May 2026.
Testing tubes full of blood are seen in Washington, U.S., February 16, 2016. REUTERS/Gary Cameron Purchase Licensing Rights, opens new tab
June 2 (Reuters) - Legend Biotech's (LEGN.O), opens new tab experimental therapy showed early signs that its approach of generating disease-fighting cells within patients may work for a type of blood cancer, sending shares of the company up nearly 30%.
Unlike traditional CAR‑T therapies that require extracting, modifying and reinfusing a patient's immune cells, Legend aims to generate them inside the body using its in vivo dual-targeting therapy, LB2501.
Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.
In the highly anticipated early-stage trial data reported on Tuesday, 12 patients with relapsed/refractory B-cell non-Hodgkin lymphoma were treated across two dose levels as of April 1.
In the higher-dose cohort, the preliminary data showed all six patients responded, while five had a complete response.
The data points "to a potentially best-in-class profile in the in vivo CAR-T space and best-in-disease profile in NHL," Oppenheimer analyst Kostas Biliouris said, adding that it strengthened chances of Legend's acquisition.
Several pharmaceutical companies including AstraZeneca (AZN.L), opens new tab and Eli Lilly (LLY.N), opens new tab have recently struck deals in the in vivo CAR-T field.
LB2501 is designed to generate CAR-T cells directly within the patient through a single, direct infusion, eliminating the need for ex vivo cell engineering and manufacturing.
"By generating CAR-T cells directly within the patient, this approach has the potential to simplify treatment delivery and expand access for patients who may not be able to receive traditional CAR-T cell therapies," said CEO Ying Huang.
While a longer follow-up was warranted, the data highlights the potential of LB2501 as a scalable, readily accessible "off-the-shelf" immunotherapy for B-cell malignancies, Legend said.
It did not provide additional dose-level details and said further data would be shared at a medical meeting later this month.
The company said no dose-limiting toxicities, serious adverse events or fatal cases were reported. Infusion-related reactions occurred in nine patients, but were resolved within a two-day median, it said.
Reporting by Sriparna Roy and Mariam Sunny in Bengaluru; Editing by Pooja Desai
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Legend Biotech (LEGN) remains a buy as Carvykti's earlier-line use drives superior efficacy, safety, and manufacturing success, signaling a structural shift in multiple myeloma therapy. Recent CARTITUDE-4 data show earlier Carvykti use extends progression-free and overall survival, with Parkinsonism rates falling below 1%, reinforcing its clinical and commercial momentum. LB2102's early Phase 1 results in solid tumors, with up to 28.6% ORR and manageable toxicity, offer promising optionality beyond hematologic cancers, though confirmation in larger trials is needed.
Exchange Traded Concepts LLC lifted its position in Houlihan Lokey, Inc. (NYSE:HLI – Free Report) by 26.9% in the fourth quarter, according to the company in its most recent 13F filing with the Securities & Exchange Commission. The firm owned 17,543 shares of the financial services provider’s stock after purchasing an additional 3,717 shares during the quarter. Exchange Traded Concepts LLC’s holdings in Houlihan Lokey were worth $3,056,000 at the end of the most recent quarter.
Other hedge funds have also recently added to or reduced their stakes in the company. Mayflower Financial Advisors LLC acquired a new stake in shares of Houlihan Lokey in the 3rd quarter worth $230,335,000. Norges Bank acquired a new position in shares of Houlihan Lokey during the second quarter worth about $126,723,000. Thrivent Financial for Lutherans increased its stake in shares of Houlihan Lokey by 75.6% during the third quarter. Thrivent Financial for Lutherans now owns 713,494 shares of the financial services provider’s stock worth $146,495,000 after acquiring an additional 307,214 shares during the period. Qube Research & Technologies Ltd raised its holdings in Houlihan Lokey by 153.8% during the second quarter. Qube Research & Technologies Ltd now owns 274,387 shares of the financial services provider’s stock worth $49,376,000 after purchasing an additional 166,285 shares in the last quarter. Finally, Capital Research Global Investors raised its holdings in Houlihan Lokey by 19.7% during the third quarter. Capital Research Global Investors now owns 956,441 shares of the financial services provider’s stock worth $196,376,000 after purchasing an additional 157,605 shares in the last quarter. Hedge funds and other institutional investors own 78.07% of the company’s stock.
Insider Buying and Selling In other Houlihan Lokey news, Director Robert A. Schriesheim sold 5,000 shares of Houlihan Lokey stock in a transaction that occurred on Friday, February 6th. The shares were sold at an average price of $170.86, for a total value of $854,300.00. Following the completion of the sale, the director directly owned 27,982 shares of the company’s stock, valued at approximately $4,781,004.52. The trade was a 15.16% decrease in their position. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is accessible through this hyperlink. Also, General Counsel Christopher M. Crain sold 500 shares of the business’s stock in a transaction on Friday, January 2nd. The shares were sold at an average price of $174.17, for a total value of $87,085.00. The disclosure for this sale is available in the SEC filing. 22.83% of the stock is currently owned by company insiders.
Analyst Ratings Changes A number of equities research analysts have weighed in on the company. Keefe, Bruyette & Woods lowered their price objective on Houlihan Lokey from $218.00 to $214.00 and set an “outperform” rating on the stock in a report on Thursday, January 29th. UBS Group cut their target price on Houlihan Lokey from $196.00 to $163.00 and set a “neutral” rating for the company in a research note on Thursday, March 12th. The Goldman Sachs Group decreased their price target on Houlihan Lokey from $243.00 to $210.00 and set a “buy” rating on the stock in a research note on Thursday, March 12th. Weiss Ratings lowered Houlihan Lokey from a “buy (b-)” rating to a “hold (c+)” rating in a report on Monday, March 9th. Finally, BMO Capital Markets increased their price objective on Houlihan Lokey from $209.00 to $211.00 and gave the stock an “outperform” rating in a research report on Thursday, January 29th. Five research analysts have rated the stock with a Buy rating and four have given a Hold rating to the company. Based on data from MarketBeat, Houlihan Lokey presently has a consensus rating of “Moderate Buy” and a consensus target price of $204.57.
Read Our Latest Analysis on HLI
Houlihan Lokey Price Performance HLI stock opened at $143.47 on Wednesday. The company’s 50 day simple moving average is $159.85 and its 200-day simple moving average is $177.03. The firm has a market capitalization of $10.01 billion, a PE ratio of 22.04 and a beta of 0.95. Houlihan Lokey, Inc. has a 12 month low of $134.41 and a 12 month high of $211.78.
Houlihan Lokey (NYSE:HLI – Get Free Report) last issued its quarterly earnings data on Thursday, January 29th. The financial services provider reported $1.94 earnings per share (EPS) for the quarter, topping the consensus estimate of $1.85 by $0.09. Houlihan Lokey had a return on equity of 24.46% and a net margin of 16.91%.During the same quarter in the prior year, the company posted $1.64 earnings per share. Houlihan Lokey’s revenue was up 13.0% on a year-over-year basis. As a group, sell-side analysts anticipate that Houlihan Lokey, Inc. will post 5.98 earnings per share for the current year.
Houlihan Lokey Announces Dividend The company also recently disclosed a quarterly dividend, which was paid on Sunday, March 15th. Investors of record on Monday, March 2nd were paid a dividend of $0.60 per share. The ex-dividend date of this dividend was Monday, March 2nd. This represents a $2.40 annualized dividend and a dividend yield of 1.7%. Houlihan Lokey’s dividend payout ratio is presently 36.87%.
About Houlihan Lokey (Free Report)
Houlihan Lokey, Inc is a global investment bank and financial services firm founded in 1972 and headquartered in Los Angeles, California. The company specializes in advisory services across a broad range of transaction types and financial matters. Since its founding, Houlihan Lokey has grown to serve corporations, financial sponsors, and government entities worldwide, providing expertise in complex and high-stakes engagements.
The firm’s core service offerings include mergers and acquisitions advisory, capital markets advisory, financial restructuring and distressed M&A, and valuation and fairness opinions.
Further Reading Five stocks we like better than Houlihan Lokey Want to see what other hedge funds are holding HLI? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Houlihan Lokey, Inc. (NYSE:HLI – Free Report).
Receive News & Ratings for Houlihan Lokey Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Houlihan Lokey and related companies with MarketBeat.com's FREE daily email newsletter.
« PREVIOUS HEADLINEViridian Therapeutics (NASDAQ:VRDN) Price Target Cut to $36.00 by Analysts at The Goldman Sachs Group
NEXT HEADLINE »MiniMed Group (NASDAQ:MMED) Now Covered by Analysts at William Blair
Explore the exciting world of Houlihan Lokey (HLI 0.14%) with our contributing expert analysts in this Motley Fool Scoreboard episode. Check out the video below to gain valuable insights into market trends and potential investment opportunities!
*Stock prices used were the prices of Feb. 11, 2026. The video was published on April 9, 2026.
Anand Chokkavelu has no position in any of the stocks mentioned. Jason Hall has no position in any of the stocks mentioned. Lou Whiteman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Houlihan Lokey. The Motley Fool has a disclosure policy.
LOS ANGELES--(BUSINESS WIRE)--Houlihan Lokey, Inc. (NYSE:HLI), the global investment bank, today announced that it will release its fourth quarter and full year results for the 2026 fiscal year on Wednesday, May 6, 2026, after the close of trading on the New York Stock Exchange. Houlihan Lokey will host a conference call at 5:00 p.m. (ET) that same day to review the results. On the call, Scott Adelson, Chief Executive Officer, and Lindsey Alley, Chief Financial Officer, will discuss the fiscal.
Investors with an interest in Financial - Miscellaneous Services stocks have likely encountered both XP Inc.A (XP - Free Report) and Houlihan Lokey (HLI - Free Report) . But which of these two stocks offers value investors a better bang for their buck right now? We'll need to take a closer look.
We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The proven Zacks Rank emphasizes companies with positive estimate revision trends, and our Style Scores highlight stocks with specific traits.
XP Inc.A and Houlihan Lokey are sporting Zacks Ranks of #2 (Buy) and #3 (Hold), respectively, right now. This system places an emphasis on companies that have seen positive earnings estimate revisions, so investors should feel comfortable knowing that XP is likely seeing its earnings outlook improve to a greater extent. But this is only part of the picture for value investors.
Value investors also tend to look at a number of traditional, tried-and-true figures to help them find stocks that they believe are undervalued at their current share price levels.
Our Value category grades stocks based on a number of key metrics, including the tried-and-true P/E ratio, the P/S ratio, earnings yield, and cash flow per share, as well as a variety of other fundamentals that value investors frequently use.
XP currently has a forward P/E ratio of 9.91, while HLI has a forward P/E of 18.41. We also note that XP has a PEG ratio of 0.65. This popular figure is similar to the widely-used P/E ratio, but the PEG ratio also considers a company's expected EPS growth rate. HLI currently has a PEG ratio of 1.14.
Another notable valuation metric for XP is its P/B ratio of 2.6. Investors use the P/B ratio to look at a stock's market value versus its book value, which is defined as total assets minus total liabilities. By comparison, HLI has a P/B of 4.89.
These are just a few of the metrics contributing to XP's Value grade of A and HLI's Value grade of C.
XP stands above HLI thanks to its solid earnings outlook, and based on these valuation figures, we also feel that XP is the superior value option right now.
PJT Partners (PJT - Free Report) came out with quarterly earnings of $1.54 per share, beating the Zacks Consensus Estimate of $1.51 per share. This compares to earnings of $1.05 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +1.99%. A quarter ago, it was expected that this investment bank would post earnings of $2.41 per share when it actually produced earnings of $2.55, delivering a surprise of +5.81%.
Over the last four quarters, the company has surpassed consensus EPS estimates four times.
PJT Partners, which belongs to the Zacks Financial - Miscellaneous Services industry, posted revenues of $418.2 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 2.75%. This compares to year-ago revenues of $324.53 million. The company has topped consensus revenue estimates three times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
PJT Partners shares have lost about 6.8% since the beginning of the year versus the S&P 500's gain of 4.8%.
What's Next for PJT Partners?While PJT Partners has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for PJT Partners was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.58 on $426 million in revenues for the coming quarter and $7.65 on $1.89 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Financial - Miscellaneous Services is currently in the top 27% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Houlihan Lokey (HLI - Free Report) , another stock in the same industry, has yet to report results for the quarter ended March 2026. The results are expected to be released on May 6.
This investment banking company is expected to post quarterly earnings of $1.84 per share in its upcoming report, which represents a year-over-year change of -6.1%. The consensus EPS estimate for the quarter has been revised 4.5% lower over the last 30 days to the current level.
Houlihan Lokey's revenues are expected to be $687.1 million, up 3.1% from the year-ago quarter.
Houlihan Lokey (HLI - Free Report) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.
The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 6. On the other hand, if they miss, the stock may move lower.
While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.
Zacks Consensus EstimateThis investment banking company is expected to post quarterly earnings of $1.84 per share in its upcoming report, which represents a year-over-year change of -6.1%.
Revenues are expected to be $687.1 million, up 3.1% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 4.48% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Houlihan Lokey?For Houlihan Lokey, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -4.12%.
On the other hand, the stock currently carries a Zacks Rank of #3.
So, this combination makes it difficult to conclusively predict that Houlihan Lokey will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Houlihan Lokey would post earnings of $1.85 per share when it actually produced earnings of $1.94, delivering a surprise of +4.86%.
Over the last four quarters, the company has beaten consensus EPS estimates four times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Houlihan Lokey doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
An Industry Player's Expected ResultsUpstart Holdings, Inc. (UPST - Free Report) , another stock in the Zacks Financial - Miscellaneous Services industry, is expected to report earnings per share of $0.39 for the quarter ended March 2026. This estimate points to a year-over-year change of +30%. Revenues for the quarter are expected to be $289.36 million, up 35.6% from the year-ago quarter.
The consensus EPS estimate for Upstart has remained unchanged over the last 30 days. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +6.03%.
When combined with a Zacks Rank of #3 (Hold), this Earnings ESP indicates that Upstart will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Investors in Houlihan Lokey, Inc. (HLI - Free Report) need to pay close attention to the stock based on moves in the options market lately. That is because the June 18, 2026 $105.00 Call had some of the highest implied volatility of all equity options today.
What is Implied Volatility?Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell-off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.
What do the Analysts Think?Clearly, options traders are pricing in a big move for Houlihan Lokey shares, but what is the fundamental picture for the company? Currently, Houlihan Lokey is a Zacks Rank #3 (Hold) in the Financial - Miscellaneous Services industry that ranks in the Top 26% of our Zacks Industry Rank. Over the last 60 days, one analyst has increased the earnings estimate for the current quarter, while two have dropped their estimates. The net effect has taken our Zacks Consensus Estimate for the current quarter from $2.24 per share to $2.14 in that period.
Given the way analysts feel about Houlihan Lokey right now, this huge implied volatility could mean there’s a trade developing. Oftentimes, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected.
Coinbase Global, Inc. (COIN - Free Report) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.
The earnings report, which is expected to be released on May 7, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.
Zacks Consensus EstimateThis company is expected to post quarterly earnings of $0.36 per share in its upcoming report, which represents a year-over-year change of -81.4%.
Revenues are expected to be $1.5 billion, down 26.1% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 10.8% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Coinbase Global?For Coinbase Global, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -18.69%.
On the other hand, the stock currently carries a Zacks Rank of #3.
So, this combination makes it difficult to conclusively predict that Coinbase Global will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Coinbase Global would post earnings of $0.92 per share when it actually produced earnings of $0.66, delivering a surprise of -28.26%.
Over the last four quarters, the company has beaten consensus EPS estimates two times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Coinbase Global doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Expected Results of an Industry PlayerHoulihan Lokey (HLI - Free Report) , another stock in the Zacks Financial - Miscellaneous Services industry, is expected to report earnings per share of $1.84 for the quarter ended March 2026. This estimate points to a year-over-year change of -6.1%. Revenues for the quarter are expected to be $687.1 million, up 3.1% from the year-ago quarter.
Over the last 30 days, the consensus EPS estimate for Houlihan Lokey has been revised 4.5% down to the current level. Nevertheless, the company now has an Earnings ESP of -4.12%, reflecting a lower Most Accurate Estimate.
This Earnings ESP, combined with its Zacks Rank #3 (Hold), makes it difficult to conclusively predict that Houlihan Lokey will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
